Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Due to our continued growth we are seeking a Regulatory and Site Start Up Specialist based in Hong Kong.

The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation. The RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines.

Essential functions of the job include but are not limited to:
• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
• Prepare. review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.
• May support process improvement initiatives, training, and mentoring.
• Performs other duties as assigned by management.

Requirement:
• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Strong communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
Preferred:
• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country.
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a CRA II (Based in Shanghai/Beijing)

Position Summary:

The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology trial experience preferred

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for an CRA II (based in Shanghai and Beijing or Taiwan)

Position Summary:

The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology experience； 
• Global Clinical Trial experience

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for an Senior / CRA  (based in HongKong)

Position Summary:

The CRA  provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology experience； 
• Global Clinical Trial experience

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Due to our continued growth we are seeking a Regulatory and Site Start Up Specialist based in Shanghai / Beijing.

The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation. The RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines.

Essential functions of the job include but are not limited to:
• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
• Prepare. review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.
• May support process improvement initiatives, training, and mentoring.
• Performs other duties as assigned by management.

Requirement:
• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Strong communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
Preferred:
• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country.
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Due to our continued growth we are seeking a Regulatory and Site Start Up Specialist based in Shanghai / Beijing.

The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation. The RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines.

Essential functions of the job include but are not limited to:
• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
• Prepare. review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.
• May support process improvement initiatives, training, and mentoring.
• Performs other duties as assigned by management.

Requirement:
• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Strong communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
Preferred:
• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country.
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a CRA II (Based in Shanghai/Beijing)

Position Summary:

The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology trial experience preferred

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

The mission of Speechify is to make sure that reading is never a barrier to learning.

Over 50 million people use Speechify’s text-to-speech products to turn whatever they’re reading – PDFs, books, Google Docs, news articles, websites – into audio, so they can read faster, read more, and remember more. Speechify’s text-to-speech reading products include its iOS app, Android App, Mac App, Chrome Extension, and Web App. Google recently named Speechify the Chrome Extension of the Year and Apple named Speechify its 2025 Design Award winner for Inclusivity.  

Today, nearly 200 people around the globe work on Speechify in a 100% distributed setting – Speechify has no office. These include frontend and backend engineers, AI research scientists, and others from Amazon, Microsoft, and Google, leading PhD programs like Stanford, high growth startups like Stripe, Vercel, Bolt, and many founders of their own companies.

Overview

The responsibilities of our Platform team include building and maintaining all backend services, including, but not limited to, payments, analytics, subscriptions, new products, text to speech, and external APIs.

This is a key role and ideal for someone who thinks strategically, enjoys fast-paced environments, is passionate about making product decisions, and has experience building great user experiences that delight users.

We are a flat organization that allows anyone to become a leader by showing excellent technical skills and delivering results consistently and fast. Work ethic, solid communication skills, and obsession with winning are paramount. 

Our interview process involves several technical interviews and we aim to complete them within 1 week. 

What You’ll Do

• Design, develop, and maintain robust APIs including public TTS API, internal APIs like Payment, Subscription, Auth and Consumption Tracking, ensuring they meet business and scalability requirements
• Oversee the full backend API landscape, enhancing and optimizing for performance and maintainability
• Collaborate on B2B solutions, focusing on customization and integration needs for enterprise clients
• Work closely with cross-functional teams to align backend architecture with overall product strategy and user experience

An Ideal Candidate Should Have

• Proven experience in backend development: TS/Node (required)
• Direct experience with GCP and knowledge of AWS, Azure, or other cloud providers
• Efficiency in ideation and implementation, prioritizing tasks based on urgency and impact
• Preferred: Experience with Docker and containerized deployments
• Preferred: Proficiency in deploying high availability applications on Kubernetes

What We Offer

• A dynamic environment where your contributions shape the company and its products
• A team that values innovation, intuition, and drive
• Autonomy, fostering focus and creativity
• The opportunity to have a significant impact in a revolutionary industry
• Competitive compensation, a welcoming atmosphere, and a commitment to an exceptional asynchronous work culture
• The privilege of working on a product that changes lives, particularly for those with learning differences like dyslexia, ADD, and more
• An active role at the intersection of artificial intelligence and audio – a rapidly evolving tech domain

Think you’re a good fit for this job? 

Tell us more about yourself and why you're interested in the role when you apply.
And don’t forget to include links to your portfolio and LinkedIn.

Not looking but know someone who would make a great fit? 

Refer them! 

Speechify is committed to a diverse and inclusive workplace. 

Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

Senior Data Architect

Design the blueprint. Architect the future. Empower data transformation.

The Role
Capco is seeking a Senior Data Architect to lead and deliver complex data architecture initiatives across our financial services clients. In this senior consulting role, you’ll guide clients through their data transformation journeys, defining strategy, designing architecture, and building scalable, cloud-based platforms. You’ll also contribute to shaping Capco’s modern data architecture offerings.

What You’ll Do

• Lead agile consulting projects focused on modern data architecture and cloud transformation
• Define and implement scalable enterprise data strategies across programmes and business units
• Design and deliver data platforms using cloud-native technologies on AWS, Azure, or GCP
• Drive integration of data governance, cataloguing, privacy, and metadata capabilities
• Act as a subject matter expert to clients, presenting technical concepts in a business context

What We’re Looking For

• Proven experience in data architecture, cloud data engineering, and enterprise platform design
• Deep knowledge of modelling practices including contextual, logical, and physical data modelling
• Hands-on experience with cloud-based data ecosystems (AWS, Azure, GCP) and modern data stacks
• Understanding of cloud data migration, data management tools, and security frameworks
• Strong communication skills to engage stakeholders across technical and non-technical teams

Bonus Points For

• Data or cloud architecture certifications (e.g., AWS, Azure, GCP, Databricks)
• Experience in data lake design and large-scale data migrations
• Familiarity with graph computing and semantic data modelling
• Background in Financial Services with stakeholder management in complex environments
• Ability to lead teams and contribute to the development of Capco’s data architecture propositions

Why Join Capco

• Deliver high-impact technology solutions for Tier 1 financial institutions
• Work in a collaborative, flat, and entrepreneurial consulting culture
• Access continuous learning, training, and industry certifications
• Be part of a team shaping the future of digital financial services
• Help shape the future of digital transformation across Financial Services.

We have been informed of several recruitment scams targeting the public. We strongly advise you to verify identities before engaging in recruitment related communication. All official Capco communication will be conducted via a Capco recruiter.

The mission of Speechify is to make sure that reading is never a barrier to learning.

Over 50 million people use Speechify’s text-to-speech products to turn whatever they’re reading – PDFs, books, Google Docs, news articles, websites – into audio, so they can read faster, read more, and remember more. Speechify’s text-to-speech reading products include its iOS app, Android App, Mac App, Chrome Extension, and Web App. Google recently named Speechify the Chrome Extension of the Year and Apple named Speechify its 2025 Design Award winner for Inclusivity.  

Today, nearly 200 people around the globe work on Speechify in a 100% distributed setting – Speechify has no office. These include frontend and backend engineers, AI research scientists, and others from Amazon, Microsoft, and Google, leading PhD programs like Stanford, high growth startups like Stripe, Vercel, Bolt, and many founders of their own companies.

Overview

We're looking to hire for our Data side of our AI team at Speechify. This role is responsible for all aspects of data collection to support our model training operations. We are able to build high-quality datasets at petabyte-scale and low cost through a tight integration of infrastructure, engineering, and research work. We are looking for a skilled Software Engineer to join us.

What You’ll Do

• Be scrappy to find new sources of audio data and bring it into our ingestion pipeline
• Operate and extend the cloud infrastructure for our ingestion pipeline, currently running on GCP and managed with Terraform.
• Collaborate closely with our Scientists to shift the cost/throughput/quality frontier, delivering richer data at bigger scale and lower cost to power our next-generation models.
• Collaborate with others on the AI Team and Speechify Leadership to craft the AI Team’s dataset roadmap to power Speechify’s next-generation consumer and enterprise products.

An Ideal Candidate Should Have

• BS/MS/PhD in Computer Science or a related field.
• 5+ years of industry experience in software development.
• Proficiency with bash/Python scripting in Linux environments
• Proficiency in Docker and Infrastructure-as-Code concepts and professional experience with at least one major Cloud Provider (we use GCP)
• Experience with web crawlers, large-scale data processing workflows is a plus
• Ability to handle multiple tasks and adapt to changing priorities.
• Strong communication skills, both written and verbal.

What we offer

• A fast-growing environment where you can help shape the company and product.
• An entrepreneurial-minded team that supports risk, intuition, and hustle.
• A hands-off management approach so you can focus and do your best work.
• An opportunity to make a big impact in a transformative industry.
• Competitive salaries, a friendly and laid-back atmosphere, and a commitment to building a great asynchronous culture.
• Opportunity to work on a life-changing product that millions of people use.
• Build products that directly impact and support people with learning differences like dyslexia, ADD, low vision, concussions, autism, and more.
• Work in one of the fastest-growing sectors of tech, the intersection of artificial intelligence and audio.

Think you’re a good fit for this job? 

Tell us more about yourself and why you're interested in the role when you apply.
And don’t forget to include links to your portfolio and LinkedIn.

Not looking but know someone who would make a great fit? 

Refer them! 

Speechify is committed to a diverse and inclusive workplace. 

Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

Mission

Speechify is the easiest way to listen to the world’s information. Articles on the web, documents in the cloud, books on your phone. We absorb it all and let you listen to it at your desk, on the go, at your own speed, and with tools that make learning easier, deeper, and faster.

What streaming services have done for audio entertainment, we’re doing for audio information. And whatever we’re doing seems to be working. We’re #1 in our category, and experiencing exponential growth.

Overview

We're looking for a Senior Software Engineer to join our Core Experiences Team. This team builds and maintains the foundational services and SDKs that power Speechify’s product experience across platforms. It's a critical role for someone who enjoys working at the intersection of product and infrastructure, thinks strategically, and is passionate about designing clear, reliable APIs and simple systems that directly enhance the user experience.

What You’ll Do

• Collaborate with Speechify’s Product Teams to scope projects, find ways to reduce scope to get faster feedback from customers, navigate the integration/UX tradeoffs relevant to different product teams, and deliver solutions via our cross-platform SDK
• Optimize existing functionality to ship things like faster loading and more intelligent parsing by designing more efficient abstractions and improving our algorithms
• Ship cloud functions, lightweight backend services, and jobs using Kotlin

An Ideal Candidate Should Have

• Systems thinking. You know that optimizing a system requires end-to-end design, and you believe simplicity is valuable.
• Speed. You work quickly to generate ideas and options and know how to decide which things can ship now and what things need time
• Focus. We’re a high-growth startup with a busy, remote team. You know how and when to engage or be heads down
• Collaboration. You know how to inspire, play, and negotiate with opinionated designers, marketers, and PMs
• Preferred Tech Stack:
  • Kotlin Multiplatform (Java experience is OK but role is Kotlin Multiplatform) 
  • Prior experience with GCP is a plus

What We Offer

• A fast-growing environment where you can help shape the company and product.
• An entrepreneurial-minded team that supports risk, intuition, and hustle.
• A hands-off management approach so you can focus and do your best work.
• An opportunity to make a big impact in a transformative industry.
• Competitive salaries, a friendly and laid-back atmosphere, and a commitment to building a great asynchronous culture.
• Opportunity to work on a life-changing product that millions of people use.
• Build products that directly impact and support people with learning differences like dyslexia, ADD, low vision, concussions, autism, and more.
• Work in one of the fastest growing sectors of tech, the intersection of artificial intelligence and audio.

Think you’re a good fit for this job? 

Tell us more about yourself and why you're interested in the role when you apply.
And don’t forget to include links to your portfolio and LinkedIn.

Not looking but know someone who would make a great fit? 

Refer them! 

Speechify is committed to a diverse and inclusive workplace. 

Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

The mission of Speechify is to make sure that reading is never a barrier to learning.

Over 50 million people use Speechify’s text-to-speech products to turn whatever they’re reading – PDFs, books, Google Docs, news articles, websites – into audio, so they can read faster, read more, and remember more. Speechify’s text-to-speech reading products include its iOS app, Android App, Mac App, Chrome Extension, and Web App. Google recently named Speechify the Chrome Extension of the Year and Apple named Speechify its 2025 Design Award winner for Inclusivity.  

Today, nearly 200 people around the globe work on Speechify in a 100% distributed setting – Speechify has no office. These include frontend and backend engineers, AI research scientists, and others from Amazon, Microsoft, and Google, leading PhD programs like Stanford, high growth startups like Stripe, Vercel, Bolt, and many founders of their own companies.

Overview

The responsibilities of our Platform team include building and maintaining all backend services, including, but not limited to, payments, analytics, subscriptions, new products, text to speech, and external APIs.

This is a key role and ideal for someone who thinks strategically, enjoys fast-paced environments, is passionate about making product decisions, and has experience building great user experiences that delight users.

We are a flat organization that allows anyone to become a leader by showing excellent technical skills and delivering results consistently and fast. Work ethic, solid communication skills, and obsession with winning are paramount. 

Our interview process involves several technical interviews and we aim to complete them within 1 week. 

What You’ll Do

• Design, develop, and maintain robust APIs including public TTS API, internal APIs like Payment, Subscription, Auth and Consumption Tracking, ensuring they meet business and scalability requirements
• Oversee the full backend API landscape, enhancing and optimizing for performance and maintainability
• Collaborate on B2B solutions, focusing on customization and integration needs for enterprise clients
• Work closely with cross-functional teams to align backend architecture with overall product strategy and user experience

An Ideal Candidate Should Have

• Proven experience in backend development: TS/Node (required)
• Direct experience with GCP and knowledge of AWS, Azure, or other cloud providers
• Efficiency in ideation and implementation, prioritizing tasks based on urgency and impact
• Preferred: Experience with Docker and containerized deployments
• Preferred: Proficiency in deploying high availability applications on Kubernetes

What We Offer

• A dynamic environment where your contributions shape the company and its products
• A team that values innovation, intuition, and drive
• Autonomy, fostering focus and creativity
• The opportunity to have a significant impact in a revolutionary industry
• Competitive compensation, a welcoming atmosphere, and a commitment to an exceptional asynchronous work culture
• The privilege of working on a product that changes lives, particularly for those with learning differences like dyslexia, ADD, and more
• An active role at the intersection of artificial intelligence and audio – a rapidly evolving tech domain

Think you’re a good fit for this job? 

Tell us more about yourself and why you're interested in the role when you apply.
And don’t forget to include links to your portfolio and LinkedIn.

Not looking but know someone who would make a great fit? 

Refer them! 

Speechify is committed to a diverse and inclusive workplace. 

Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

Scopely is looking for a Server Engineer, Tooling to join an unannounced title based in our Shanghai office (5 days in the office).

At Scopely, we care deeply about what we do and want to inspire play, every day — whether in our work environments alongside our talented colleagues, or through our deep connections with our communities of players. We are a global team of game lovers who are developing, publishing, and innovating within the mobile games industry, connecting millions of people around the world daily.

We are in the early stages of development on an ambitious mobile game in China, and we’re assembling a team of passionate game makers to craft unforgettable characters and immersive adventures that players will love.

What You Will Do

We are seeking a Server Engineer, Tooling to design, build, and optimize the core tools and infrastructure that power our backend game development and deployment workflows.

What We’re Looking For

• Experience: professional experience in software engineering, tooling, DevOps, or infrastructure engineering, with deep expertise in optimizing developer workflows and CI/CD systems at scale.
• Tooling Expertise: Advanced hands-on experience designing and optimizing build systems like Bazel and Gradle. Experience with dependency injection frameworks.
• CI/CD Expertise: Strong background in designing and maintaining CI pipelines (e.g., GitLab CI) and runner infrastructure.
• Infrastructure Skills: Strong background with cloud platforms (Alibaba Cloud, AWS, Azure, or GCP) and container orchestration (Kubernetes). Experience with Terraform or other infrastructure-as-code tools.
• Programming & Scripting: Proficiency in Go, Python, Java, Bash, or similar languages for automation, tooling, and CI workflow orchestration.
• Systems Knowledge: Strong understanding of Linux systems, networking fundamentals, security best practices, and tooling for large-scale, distributed engineering teams.
• Communication: Professional proficiency in Mandarin, bonus for English
• Education: BS / MS in Computer Science or Software Engineering or equivalent

Bonus Points

• Experience building production-grade services using Java, with strong knowledge of performance tuning, and modern development best practices
• Experience supporting large server monorepos and optimizing server development workflows for online games or high-scale applications.
• Familiarity with common testing frameworks and strategies for automated server-side testing (smoke tests, integration tests, end-to-end tests).
• Experience using AI tools to speed up the development lifecycle and improve efficiency

Scopely is looking for a Senior/Staff Server Engineer to join an unannounced title based in our Shanghai office (5 days in the office).

At Scopely, we care deeply about what we do and want to inspire play, every day - whether in our work environments alongside our talented colleagues, or through our deep connections with our communities of players. We are a global team of game lovers who are developing, publishing and innovating the mobile games industry, connecting millions of people around the world daily. 

We are in the early stages of development on an ambitious mobile game in China, and we’re assembling a team of passionate game makers to craft unforgettable characters and immersive adventures that players will love.

What You Will Do 

We are looking for a Server Engineer to build the next generation of our games. You will work with a team of passionate engineers while developing core systems and features that power large-scale, real-time experiences for our game. You’ll work on complex technical challenges involving real-time interaction, large-scale systems, and a persistent shared world used by tens of millions of players.

What We’re Looking For 

• Experience in building, and maintaining scalable, production-grade distributed systems. Deep understanding of networked and distributed systems, cloud security best practices, and performance optimization. Familiarity with network protocols for real-time communication, such as gRPC and WebSocket.
• Programming Languages: Proficiency in one or more of Java, Go, C#, Python
• Familiar with Git, Bash and Gradle
• Professional proficiency in both Mandarin and English
• BS / MS in Computer Science or Software Engineering or equivalent

Bonus Points 

• You have experience shipping at least one online game or app
• Experience in managing IaaS environments and deploying on cloud platforms such as Alibaba Cloud (Alicloud), AWS, Azure, or GCP. Proficiency with Kubernetes cluster management, infrastructure as code tools like Terraform
• Experience using data processing frameworks and data warehouse
• Experience using AI tools to speed up the development lifecycle and improve efficiency
• Experience leading a team: task breakdown& scoping, code reviews, mentoring junior devs, prototyping, etc. 
• Excellent verbal English communication

At Scopely, we create games for everyone - and want to ensure that the people behind our games reflect that! We are committed to creating a diverse, supportive work environment where everyone is treated with respect. We are committed to providing equal employment opportunities and welcome individuals from all backgrounds to join us & embrace the adventure!

Capco

Capco is a leading global technology and management consultancy that excels in driving digital transformation within the financial services and insurance sectors. With an unwavering commitment to delivering practical solutions, we empower our clients to navigate the complexities of today's fast-paced market. Our integrated services span across major financial hubs worldwide, ensuring that we are always close to our clients and their needs.

At Capco, we possess not only the expertise but also the vision and passion necessary to lead transformative change. As we embark on an exciting growth journey, this is the perfect moment to join our team. We are expanding geographically, increasing our workforce, and poised to disrupt the consulting landscape across APAC with our entrepreneurial spirit and agile methodologies.

About the Role

We are thrilled to introduce an opportunity for a talented AI Engineer to join our Hong Kong team. This role is designed for a technology innovator who thrives on solving complex challenges and is passionate about building AI-driven solutions that transform the Financial Services industry. As an AI Engineer at Capco, you will play a pivotal role in shaping the future of banking and insurance by leveraging cutting-edge AI technologies to deliver intelligent, scalable, and compliant solutions. Your work will enable our clients to unlock new efficiencies, enhance customer experience, and stay ahead in a rapidly evolving digital landscape. If you are excited about applying advanced AI techniques to real-world business problems and driving measurable impact, we want you on our team.

Key Responsibilities

• Build multi-agent workflows to optimize business processes within banking and financial services.
• Develop and maintain software pipelines for data processing, model training, and deployment using Python-based frameworks.
• Train, fine-tune, and optimize neural network models, including LLMs, for specific use cases such as risk assessment and customer query resolution.
• Collaborate with data scientists, engineers, and business stakeholders to translate requirements into production-ready AI applications.
• Ensure AI models adhere to banking regulations, data privacy standards (e.g., GDPR, CCPA), and ethical AI practices.
• Conduct experiments, evaluate model performance, and iterate solutions to improve accuracy and efficiency.
• Monitor deployed solutions in production, troubleshooting issues, and implement updates as needed.
• Stay updated on emerging AI trends, particularly in NLP and LLMs, and contribute to knowledge sharing within the team.
• Participate in code reviews, agile ceremonies, and CI/CD processes.

Experience and Qualifications

• 4–10 years of professional experience in AI/ML engineering, with a focus on software development and deployment.
• Strong software engineering experience with Python and libraries such as TensorFlow, PyTorch, scikit-learn, and Huggingface.
• Demonstrated experience in NLP, including projects involving text classification, entity recognition, or similar.
• Hands-on experience training and fine-tuning neural network models, with a track record of optimizing for performance and scalability.
• Proven expertise working with LLMs (e.g., GPT, BERT) and building agentic solutions using frameworks like LangChain, LangGraph, or ADK.
• Familiarity with cloud platforms (AWS, Azure, or Google Cloud) for model deployment and data management.
• Solid understanding of machine learning concepts, including supervised/unsupervised learning, evaluation metrics, and bias mitigation.
• Experience with version control systems (e.g., Git) and agile methodologies.
• Excellent problem-solving skills and ability to work in a fast-paced, collaborative environment.

Preferred Qualifications

• Experience in financial services domains such as fraud detection, credit scoring, or customer service automation.
• Familiarity with big data tools (e.g., Spark, Hadoop) and databases (SQL/NoSQL).
• Knowledge of graph databases and knowledge graphs.
• Understanding DevOps practices, containerization (Docker, Kubernetes), and MLOps workflows.
• Publications, open-source contributions, or certifications in AI/ML.
• Strong communication skills for presenting technical concepts to non-technical stakeholders.

At Visual Concepts, we believe great games are made by diverse and empowered teams with a shared passion for play. As one of the world’s top game development studios, we have shipped over 100 multi-sku titles to critical acclaim and commercial success. Our teams are independent and ambitious. Our studios in Novato, Irvine, Budapest, Shanghai, Austin, Boise, Seoul and Parksville, Canada are committed to artistry and ground breaking technology, offering top candidates the opportunity to learn and grow with some of the hardest working and most creative minds in the industry.

Visual Concepts China (Shanghai) is seeking a Senior Full-Stack Server Engineer to join our studio for an unannounced project. Widely regarded as one of the world’s top video game studios, Visual Concepts, a subsidiary of Take-Two Interactive Software, Inc. (TTWO). Visual Concepts is best known for some of the world’s greatest sports videogames, including the world’s #1-rated and #1-selling basketball franchise, NBA 2K.

What We Need:

We are looking for a  backend specialist, responsible for designing, developing, and maintaining robust, scalable, and secure server-side applications and APIs. This role requires solid, hands-on experience in server API setup and configuration, along with a strong solid understanding of database storage solutions.

Who Will Be A Great Fit:

• Experience: 8-10 years of professional experience in software development, with at least 5 years focused on high-scale backend server engineering
• Server API Mastery: Demonstrable expertise in designing, building, documenting, and consuming complex server APIs (REST/GraphQL). Must have experience with API gateways and service-to-service communication
• Proficiency in major backend languages (e.g., Python, Java, C++)
• Database Proficiency: Strong solid understanding of relational databases (e.g., PostgreSQL, MySQL, MS SQL Server) including query optimization, indexing, and schema design. Good understanding on in-memory database solutions as well as NoSQL databases for scaling across machine clusters
• Cloud Computing: Hands-on experience deploying and managing applications on at least one major cloud platform (AWS, Azure, or GCP)
• Expert knowledge of various testing methodologies and requirements (unit, integration, BVT, stress and performance testing). Able to setup testable framework for automation and white-box testing
• Bachelor or higher degree (or its equivalent) in Computer science, Computer engineering or a directly related field
• Love for video games (not just ours!)

Might Be Nice:

• Experience deploying large-scale microservices and distributed systems
• Good understanding of networking, data storage and security
• Experience with Infrastructure as Code (IaC) tools like Terraform, AWS CloudFormation, Google Cloud Deployment Manager or Azure Resource Manager
• Understanding of a heavily regulated or high-traffic environment (e.g., FinTech, e-commerce, telecommunications)
• Prior experience in leading technical projects and mentoring junior engineers

please email: hrcn@vcentertainment.com

To learn more about Visual Concepts and our studio locations, check out our website at www.vcentertainment.com

At Visual Concepts, we believe great games are made by diverse and empowered teams with a shared passion for play. As one of the world’s top game development studios, we have shipped over 100 multi-sku titles to critical acclaim and commercial success. Our teams are independent and ambitious. Our studios in Novato, Irvine, Budapest, Shanghai, Austin, Boise, Seoul and Parksville, Canada are committed to artistry and ground breaking technology, offering top candidates the opportunity to learn and grow with some of the hardest working and most creative minds in the industry.

Visual Concepts China (Shanghai) is seeking a Senior Full-Stack Server Engineer to join our studio for an unannounced project. Widely regarded as one of the world’s top video game studios, Visual Concepts, a subsidiary of Take-Two Interactive Software, Inc. (TTWO). Visual Concepts is best known for some of the world’s greatest sports videogames, including the world’s #1-rated and #1-selling basketball franchise, NBA 2K.

What We Need:

We are looking for a  backend specialist, responsible for designing, developing, and maintaining robust, scalable, and secure server-side applications and APIs. This role requires solid, hands-on experience in server API setup and configuration, along with a strong solid understanding of database storage solutions.

Who Will Be A Great Fit:

• Experience: 8-10 years of professional experience in software development, with at least 5 years focused on high-scale backend server engineering
• Server API Mastery: Demonstrable expertise in designing, building, documenting, and consuming complex server APIs (REST/GraphQL). Must have experience with API gateways and service-to-service communication
• Proficiency in major backend languages (e.g., Python, Java, C++)
• Database Proficiency: Strong solid understanding of relational databases (e.g., PostgreSQL, MySQL, MS SQL Server) including query optimization, indexing, and schema design. Good understanding on in-memory database solutions as well as NoSQL databases for scaling across machine clusters
• Cloud Computing: Hands-on experience deploying and managing applications on at least one major cloud platform (AWS, Azure, or GCP)
• Expert knowledge of various testing methodologies and requirements (unit, integration, BVT, stress and performance testing). Able to setup testable framework for automation and white-box testing
• Bachelor or higher degree (or its equivalent) in Computer science, Computer engineering or a directly related field
• Love for video games (not just ours!)

Might Be Nice:

• Experience deploying large-scale microservices and distributed systems
• Good understanding of networking, data storage and security
• Experience with Infrastructure as Code (IaC) tools like Terraform, AWS CloudFormation, Google Cloud Deployment Manager or Azure Resource Manager
• Understanding of a heavily regulated or high-traffic environment (e.g., FinTech, e-commerce, telecommunications)
• Prior experience in leading technical projects and mentoring junior engineers

please email: hrcn@vcentertainment.com

To learn more about Visual Concepts and our studio locations, check out our website at www.vcentertainment.com

WEKA is architecting a new approach to the enterprise data stack built for the age of reasoning. NeuralMesh by WEKA sets the standard for agentic AI data infrastructure with a cloud and AI-native software solution that can be deployed anywhere. It transforms legacy data silos into data pipelines that dramatically increase GPU utilization and make AI model training and inference, machine learning, and other compute-intensive workloads run faster, work more efficiently, and consume less energy.

WEKA is a pre-IPO, growth-stage company on a hyper-growth trajectory. We’ve raised $375M in capital with dozens of world-class venture capital and strategic investors. We help the world’s largest and most innovative enterprises and research organizations, including 12 of the Fortune 50, achieve discoveries, insights, and business outcomes faster and more sustainably. We’re passionate about solving our customers’ most complex data challenges to accelerate intelligent innovation and business value. If you share our passion, we invite you to join us on this exciting journey.

What you'll be doing:

The regional Senior Sales Engineer in China will join our rapidly growing sales organization. Being a WEKA Sales Engineer will require you to partner with customers, understanding their needs and requirements, helping them to leverage the value and performance that WEKA can provide to their business and applications.

          Responsibilities:

• Meet with customers and partners to educate them on the technical aspects of WEKA
• Assist with evaluations and system configurations
• Build and deliver technical product and architecture presentations and demos
• Become the advocate for WEKA customers and bring feedback back to the R&D and product management organizations
• Become a technical adviser to your customers and periodically review their status and inform on possible improvements
• Become an SME on WEKA and its ecosystem
• Contribute or lead responses to RFPs, RFQs, and RFIs
• Help in the creation and maintenance of Q&A’s, best practices, and other technical documentation
• This is a Hands-on position

          Requirements:

• Familiar with high performance IO workloads 
• Extensive filesystems system background - Experience with NFS, SMB and distributed parallel file systems
• Strong Linux OS knowledge
• Data Center networking understanding
• Experience with performance demonstrations and analysis
• Prior experience in working at a start-up company - an advantage
• Experience with running workloads in cloud hypervisors such as AWS, Azure, OCI or GCP
• Knowledge and experience in configuring and using Kubernetes
• Scripting abilities - an advantage
• Excellent verbal and written interpersonal skills

The WEKA Way:

• We are Accountable: We take full ownership, always–even when things don’t go as planned. We lead with integrity, show up with responsibility & ownership, and hold ourselves and each other to the highest standards.
• We are Brave: We question the status quo, push boundaries, and take smart risks when needed. We welcome challenges and embrace debates as opportunities for growth, turning courage into fuel for innovation.
• We are Collaborative: True collaboration isn’t only about working together. It’s about lifting one another up to succeed collectively. We are team-oriented and communicate with empathy and respect. We challenge each other and conduct positive conflict resolution. We are being transparent about our goals and results. And together, we’re unstoppable.
• We are Customer Centric: Our customers are at the heart of everything we do. We actively listen and prioritize the success of our customers, and every decision we make is driven by how we can better serve, support, and empower them to succeed. When our customers win, we win.

Concerned that you don’t meet every qualification above?

Studies have shown that women and people of color may be less likely to apply for jobs if they don’t meet every qualification specified. At WEKA, we are committed to building a diverse, inclusive and authentic workplace. If you are excited about this position but are concerned that your past work experience doesn’t match up perfectly with the job description, we encourage you to apply anyway – you may be just the right candidate for this or other roles at WEKA.

 WEKA is an equal opportunity employer that prohibits discrimination and harassment of any kind. We provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

ClickHouse is seeking an engineering manager to lead our team of software engineers based in China who own our partnership with Alibaba Cloud.

Key Responsibilities

• Build and lead a high-performing technical team in China, fostering a culture of technical excellence and customer obsession
• Support Alibaba Cloud & ClickHouse partnership with deep technical expertise, driving integration, optimization, and go-to-market strategies
• Lead enterprise customer POCs from architecture design to production deployment, translating business requirements into scalable technical solutions
• Design PB-scale real-time data warehouse architectures, leveraging ClickHouse's exceptional performance for mission-critical workloads
• Partner with global Sales, Product, and Engineering teams, representing customer needs and driving product innovation
• Represent ClickHouse at technical conferences, meetups, and community events in China

Required Qualifications

• Fluent English and Mandarin for seamless technical discussions with global teams and Chinese customers
• Outstanding customer-facing communication skills with the ability to build trusted relationships at all organizational levels
• Deep database expertise - internals, query optimization, distributed systems, OLAP technologies
• Strong architecture design capabilities for large-scale, mission-critical data platforms
• PB-scale real-time data warehouse hands-on experience building and operating production systems
• Cloud-Native proficiency - solid experience with cloud-native architecture and infrastructure, with hands-on knowledge of at least one major cloud service provider (AWS, GCP, Azure, Alibaba Cloud)
• Team leadership experience managing technical teams of 10+ engineers
• 8+ years in database/data warehouse/big data technologies
• High level of responsibility, ownership, and accountability - thrives in a high-velocity environment with significant autonomy
• Founder's mindset with a focus on impact, innovation, and delivering measurable results

Preferred Qualifications

• ClickHouse community contributor - active participation through code, documentation, or advocacy
• Experience with columnar databases (ClickHouse, Druid, Pinot) and real-time analytics systems
• Kubernetes expertise - practical experience deploying and managing stateful applications on K8s at scale
• Data engineering skills - strong background in ETL pipelines, data replication, CDC, and streaming platforms (Kafka, Flink, Spark)
• Technical writing/speaking experience - blogs, conference presentations, technical documentation
• Open-source contributions in the database or cloud-native ecosystem
• Exceptional problem-solving skills with proven experience debugging complex production issues