We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for a Contracts Manager to help support our expansion across the region and around the globe!

As a leader in the Contracts organization you will review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements. Work closely with Clinical Operations study team and play a key role to ensure deliverables are in alignment with defined study timelines.

Essential functions of the job include but are not limited to:

• Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts.
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Other tasks as assigned.

Qualifications:

Minimum Required:

• Graduate, postgraduate, 4-year college degree
• Equivalent experience ideally in a scientific or healthcare discipline
• Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements, vendor contracts and site Budget negotiations, but no less than 5 years’ experience.
• Experienced leading interactions with Study Teams and Sponsor

Preferred:

• Bachelors in law, scientific fields, business administration or equivalent degree
• Excellent organizational and communication skills and attention to detail
• Knowledgeable on setting up Contracting Plans - Guides for CTA & Budget negotiations
• Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines

Skills:

Competencies

• Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
• Executes time-sensitive matters while maintaining accuracy and attention to detail.
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
• Displays sound business judgment and a proactive, independent work style.
• Proficient in MS Office software programs and computer applications
• Handles sensitive issues with discretion.
• Works well independently and cooperatively with others to achieve common goals in a virtual environment.
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.

#LI-AG2 #LI-REMOTE

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for a Contracts & Budgets Associate to help support our expansion across the region and around the globe!

The Contracts & Budgets Associate, Site Contract Management, develops and negotiates regional study budgets based on the requirements of a study protocol, as well as reviewing, drafting, negotiating and tracking a variety of legal agreements which include confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements. The postholder works closely with the Clinical Operations study team and playing a key role in ensuring deliverables are in alignment with defined study timelines.

Essential functions of the job include but are not limited to:
• Develop, negotiate global study budgets based on the requirements of a study protocol.
• Review, draft and negotiate a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Coordinate execution of agreements
• Support the maintenance of contract files and databases, including contract archiving.
• Recognize where processes can be improved and take corrective action.
• Other tasks, as assigned.

Qualifications:

Minimum Required:
• Bachelors degree, or equivalent level of contract management experience preferably in a clinical research or similar industry setting

Other Required:
• 1 year of relevant experience drafting, reviewing and negotiating agreements related to clinical research i.e. Non-Disclosure Agreements, Clinical Trial Agreements, etc. as well as management, control and tracking of the contract process.
• Excellent organizational and communication skills and attention to detail.

Preferred:
• Post-graduate qualification

Skills & Competencies:
• Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
• Executes time-sensitive matters while maintaining accuracy and attention to detail.
• Exhibits high self-motivation and is able to work and plan with some supervision as well as in a global team environment.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
• Displays sound business judgment and a proactive, independent work style.
• Handles sensitive issues with discretion.
• Works well independently and cooperatively with others to achieve common goals in a virtual environment 
• Is proficient in MS Office software programs and computer applications.
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Start Up Lead (SUL) in Mexico!

The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:

• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• 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 IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:

• Demonstrated leadership experience in driving cross-functional activities
• Excellent 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.
• Experience using milestone tracking tools/systems

Preferred:

• Advanced degree in life sciences or related field

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.
• Excellent organizational skills.
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.
• Must demonstrate excellent computer skills.
• Excellent time management and prioritization skills to ensure deadlines are met.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Occasional travel may be required.

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Feasibility Associate to join our team at Precision for Medicine!

As part of this team, you'll support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate supports pre-award feasibility projects and support business development and operational strategy teams by conducting global feasibility analyses. The Senior Feasibility Associate supports feasibility projects for newly awarded and/or ongoing clinical trials and supports start-up and clinical teams with site identification. In addition, Senior Feasibility Associate may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to:

• Support pre-award feasibility projects
• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.
• Apply process, templates and delivery standards for feasibility pre-award.
• Provide support to post-award feasibility projects
• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Provide management of feasibility project team pertaining to the conduct of the feasibility:
• Provide training and training materials.
• Ensure accuracy and quality of the survey data.
• Oversee and /or conduct the site outreach process.
• Participate and or/contribute to feasibility KOM and feasibility progress meetings with the sponsor.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)
• Apply process, tracking, templates, data structure delivery standards for post award and stand-alone feasibility.
• Work closely with the Precision study teams to assess required input from the feasibility team, and agree on delivery plan, including roles and responsibilities, for feasibility pre- and post-award.
• Follow post and pre award feasibility process, SOPs templates and tools.

Qualifications:
Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Domestic and international travel including overnight stays.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred:

• Postgraduate degree preferred.

Skills:

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilitiesAdvanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms

Competencies:

• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Feasibility Associate to join our team at Precision for Medicine!

As part of this team, you'll support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate supports pre-award feasibility projects and support business development and operational strategy teams by conducting global feasibility analyses. The Senior Feasibility Associate supports feasibility projects for newly awarded and/or ongoing clinical trials and supports start-up and clinical teams with site identification. In addition, Senior Feasibility Associate may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to:

• Support pre-award feasibility projects
• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.
• Apply process, templates and delivery standards for feasibility pre-award.
• Provide support to post-award feasibility projects
• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Provide management of feasibility project team pertaining to the conduct of the feasibility:
• Provide training and training materials.
• Ensure accuracy and quality of the survey data.
• Oversee and /or conduct the site outreach process.
• Participate and or/contribute to feasibility KOM and feasibility progress meetings with the sponsor.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)
• Apply process, tracking, templates, data structure delivery standards for post award and stand-alone feasibility.
• Work closely with the Precision study teams to assess required input from the feasibility team, and agree on delivery plan, including roles and responsibilities, for feasibility pre- and post-award.
• Follow post and pre award feasibility process, SOPs templates and tools.

Qualifications:
Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Domestic and international travel including overnight stays.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred:

• Postgraduate degree preferred.

Skills:

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilities
• Advanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms

Competencies:

• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Regulatory and Start Up Specialist (Senior RSS) in Mexico!

As the Senior RSS on our team, you are a seasoned, experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the Senior 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 providing support to the Site Contract Management group in budget and contract negotiation.

The Senior RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities and 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 Competent Authorities (CA), Ethics Committee (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
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within Precision for Medicine 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 participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study
• May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors
• May support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries
• May mentor staff on local study start-up regulations, submissions, and internal procedures
• May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required
• Performs other duties as assigned by management

Qualifications

Minimum Required:

• Bachelors’ 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
• 3.5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Other Required:

• Excellent 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
• Ability to prioritize workload to meet deadlines

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
• Can assist junior SU specialists in problem resolution
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
• Excellent organizational skills
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
• Must demonstrate excellent computer skills
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Flexible attitude with respect to work assignments and new learning
• Occasional travel may be required

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring an Associate Compensation & Benefits Director to be responsible for the execution and administration of PMG’s international compensation and benefit plans and programs.

In this role you will be responsible for conducting analysis and interpretation related to the organization’s compensation and benefits programs for region. Supporting international salary survey participation including job matching and competitive benchmarking as well as benefit plan benchmarking. Partnering closely with HR Business Partners, Talent Acquisition, Finance, Legal, and Business Leaders to ensure market competitiveness, internal equity, and compliance across all geographies.

You will also support annual compensation (merit/promotion and bonus) planning process and all international benefit plan management and administration, including benefit plan design benchmarking and broker management.

Main Duties & Responsibilities:

• Member of the global Total Reward team while managing regional compensation and benefits matters in support of the business and local/regional HR Business Partners

Compensation Management

• Participates in annual salary administration programs, including salary grade and structure maintenance & creation
• Provides data analytics for the maintenance and development of incentive or salary increase budgets
• Participates in administration of annual incentive, and/or salary increase programs
• Conducts market benchmarking analysis to determine competitive positioning of the organizations jobs and pay programs
• Evaluates the organizations job descriptions, providing feedback and consulting to the business as needed
• Participates and manages salary surveys by matching PMG jobs to available salary surveys reference jobs and provides organizational data to these survey providers
• Lead the gender pay gap reporting process (as they become applicable… i.e. UK, France)
• Ensures HR systems are configured/maintained in a way that support overall compensation priorities and policy

Benefits Management

• Supports the development of international benefits strategy and oversee the implementation of such, ensuring the benefits offering is strategically aligned with the business, competitively attractive to employees and is cost effective
• Maintain inventory of all benefit plans and policy documents per country/business unit, including renewal dates, and tracking of costs
• Manage annual carrier/policy renewal process, working with brokers and vendors on contract negotiations and initiating periodic market reviews to ensure benefits are secured on the most competitive terms
• Partner with HR and the applicable business to assess, recommend and establish appropriate market level of benefits when PMG establishes operations in new countries and/or upon acquisition of new companies
• Lead the administration of pension schemes
• Point of contact for incoming benefits related invoices (liaison with Finance for invoice processing)
• Build external relationships and participate in international benefit surveys to ensure PMG remains aware of what other companies are doing in the competitive market
• Partner with field HR to handle employee questions and assist with processes such as leave of absence, sickness, and accidents
• Coordinate with legal team, HR team and outside counsel on immigration matters

General Responsibilities

• Partners with HRIS for ongoing data integrity checks
• Produces HR Metrics related to compensation and offer insights to the Business and HR Teams
• Provides guidance, coaching, mentoring and training to HR Business Partners on compensation-related issues
• Provides input on compensation policy and procedure creation
• Generate compensation metrics and provide analysis and recommendations based on them
• Lead and/or participates in HR and Total Reward projects
• Supports US and Global compensation matters as needed

Minimum Education & Experience:

Bachelor's degree in a related major and 12 or more years of compensation and benefits experience within mature international organizations. Experience working across different countries and general understanding of process, payroll and labor law differences.

Expertise in messaging to support compensation and benefit programs that are aimed at leadership and employees.

Preferred Education & Experience:

• Experience in Life Sciences, Pharmaceutical or other industry directly related to one of PMG’s service lines.
• Experience with PayFactors and SAP/SuccessFactors HRMS a plus.
• Experience matching jobs, as well as designing and developing a salary grade structures.
• Has worked with short term incentive plans and/or sales plans.

Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.

Knowledge, Skills, and Competencies:

• Bias for Action & Ownership: Is a “self-starter”. Proactively identifies issues; takes end-to-end accountability for outcomes
• Advanced proficiency with market pricing, survey methodology, salary structures, regression analysis, and data modeling
• Solid understanding of global regulatory environments and pay transparency legislation
• Good understanding of different cultures (both business as well as country) and demonstrates an appreciation of cultural diversity, with sensitivity to differences in attitudes and norms
• Data Analytics & Storytelling: Translates data into insights and executive-ready narratives
• Influence Without Authority: Shapes outcomes across HR, Finance, Legal, and business leaders through credibility and relationships
• Strategic Thinking & Execution: Operates at both 30,000 ft and ground level; delivers polished programs on time
• Stakeholder Management & Communication: Tailors messages to diverse audiences; simplifies complexity
• Change Leadership & Enablement: Drives adoption of new frameworks and practices through training, playbooks, and clear guidance
• Project Management Excellence: Demonstrates ability to plan, organize, and execute complex global compensation projects. Effectively manages timelines, resources, and stakeholders; communicates progress clearly; and ensures successful delivery of initiatives within scope, budget, and quality standards

#LI-AG2 #LI-REMOTE

We’re expanding our data engineering capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Clinical Data Engineer to help build the foundation of this new regional function. In this role, you’ll lead the development and optimization of clinical data systems, drive data standardization, build validation frameworks, and design high‑performance databases and pipelines across global trials.

The Senior Clinical Data Engineer leads the strategic development and optimization of clinical data systems to support regulatory compliance, advanced analytics, and operational excellence across global trials.

This role drives enterprise-level data standardization initiatives, and architects scalable validation frameworks to proactively address systemic data issues. With deep expertise in Python, R, SQL, and SAS, the engineer builds and maintains modular codebases, sets coding standards, and mentors junior engineers. The role also oversees regulatory alignment with GCP and FDA 21 CFR Part 11, establishing robust documentation and audit trail protocols. Through dynamic dashboards and analytics tools, the engineer delivers actionable insights into trial performance and data quality. As a strategic liaison across Biostatistics, Clinical Operations, and Regulatory Affairs, the engineer translates clinical requirements into scalable technical solutions and leads the design of secure, high-performance databases and ETL pipelines integrating data from diverse clinical systems.

Essential functions of the job include but are not limited to:

Data Standardization & Mapping: Spearhead the development of enterprise-level data mapping strategies that transform raw clinical data into standardized formats for high-impact analytics. Lead the adoption and governance of data standards across programs to ensure regulatory alignment and consistency.

Data Quality Assurance: Design and implement robust, scalable validation frameworks that proactively detect and resolve systemic data issues. Serve as a strategic partner to Clinical Data Managers and cross-functional teams, driving continuous improvement in data integrity across global trials

Programming & Scripting: Architect and maintain advanced, modular codebases using Python, R, SQL, and SAS to support complex data engineering workflows. Establish coding standards and mentor junior engineers in automation, reproducibility, and performance optimization. Example use cases includes edit checks, reconciliations, exception listings, programmed protocol deviations, resource projections based on site data entry volume

Regulatory Compliance & Documentation: Lead compliance initiatives to ensure all data systems and workflows meet GCP, FDA 21 CFR Part 11, and evolving global regulatory requirements. Define documentation protocols and oversee audit trail governance to support inspection readiness and transparency.
Reporting & Visualization - Develop and operationalize dynamic dashboards and analytics tools that provide real-time insights into data quality, trial progress, and operational KPIs. Translate complex datasets into actionable intelligence for clinical and regulatory stakeholders.

Collaboration & Cross-Functional Support: Act as a strategic liaison between Clinical Data Engineering and Biostatistics, Clinical Operations, and Regulatory Affairs. Translate clinical and scientific requirements into scalable technical solutions that support study execution and data delivery.

Database Design & Optimization: Lead the design and optimization of secure, high-performance relational databases and data lakes. Ensure infrastructure scalability, query efficiency, and data governance for large-scale clinical datasets.

Qualifications:

Minimum Required:

• Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience
• Minimum 6 years experience in clinical monitoring, clinical trial management or equivalent
• Advanced programming and automation skills; database design; dashboard development; CDISC governance
• Professional working proficiency in English

Other Required:

• Highly effective oral and written communication skills with the ability to communicate effectively with project team members
• Excellent organizational and time management skills
• Ability to work in a team or independently as required
• Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems and clinical systems
• Proficiency in statistical analysis and data monitoring tools.
• Detail-oriented with strong analytical and problem-solving skills
• Demonstrated experience with integrated risk planning & management
• Ability to mentor junior team members

Preferred:

• CRO experience as a Clinical Data Engineer or Programmer

Skills:

• Strong analytical and problem-solving skills with attention to data quality and integrity.
• Ability to work with large, complex datasets from multiple sources.
• Effective communication skills to collaborate with cross-functional teams.
• Knowledge of data governance, privacy, and security best practices in clinical research.

Competencies:

• Collaboration: Works effectively with clinical, statistical, and technical teams to align data strategies with study goals.
• Accountability: Takes ownership of data engineering deliverables and ensures timely, high-quality outputs.
• Adaptability: Thrives in a fast-paced, evolving environment with shifting priorities and timelines.
• Compliance-Oriented: Maintains a strong focus on regulatory compliance and data traceability.

#LI-AG2 #LI-REMOTE

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for a Principal Database Programmer to help build the foundation of our clinical data operations in LATAM. In this high‑impact role, you’ll lead the development, testing, implementation, and support of clinical databases from start-up through post‑lock, while partnering closely with Data Management, Project Management, EDC vendors, and clients.

You’ll guide database design, oversee programming activities, troubleshoot complex technical issues, support system administration, forecast project needs, and contribute to SOP and process development. This is also a unique opportunity to mentor junior programmers, train end users, support onboarding, and influence how our new regional team grows.

If you’re motivated by technical leadership, collaboration, and the chance to help shape a new regional department from the ground up, we’d love to hear from you!

Essential functions of the job include but are not limited to:

• Maintains responsibility of assigned projects. Ensures on-time delivery, communicates the status of projects to internal teams and study
• Maintains awareness of the key elements of the contract and scope of work for assigned project(s) and communicates status updates to the Project team as necessary.
• Perform project forecasting of hours, and identification of resource requirements and manages project budgets including identification of out-of-scope work and post production changes
• Provides input and guidance to the design of clinical databases to the client and internal teams
• Builds and supports clinical databases
• Develops, tests, and validates programs and clinical database to support client-related projects and third-party applications.
• Provides system administration and advanced technical support services for internally developed applications and clinical databases, client-related projects and third-party applications
• Troubleshoots and resolves software and clinical database problems
• Develops and maintains study-specific validation documents
• Provides support to data management for client-related projects from CRF design to post database close and archival
• May design, develop and validate the Company’s internal applications, client-related projects and third-party applications.
• Participate in software vendor selection
• Participate in conducting EDC demonstrations and trainings
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Supports with onboarding of new hires
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• Present software demonstrations/trainings, department/company training sessions, present at project meetings
• Performs all duties in accordance with SOPs, government regulations, guidelines and industry standards.
• May require some travel
• Perform other duties as assigned

Qualifications:

Minimum Required:

• Minimum 8 years’ experience
• Bachelors and/or a combination of related experience
• Professional working proficiency in English required

Other Required:

• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Able to handle a variety of clinical research tasks.
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral.
• Experience in Object Oriented Programming (C#, C++, VBS, etc.…),
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
• Experience in clinical database management system development.
• Experience in a clinical, scientific or healthcare discipline.
• Proficiency in more than one CDMS system to include building forms, edit checks and complex rule development.  Awareness of CRF standards and input to maintenance of standards library. Ability to troubleshoot and support peers with technical issues and build solutions.Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong leadership and interpersonal skills

Preferred:

• Experience in a clinical, scientific or healthcare discipline and multiple therapeutic area experience, preferably Oncology
• Experience in utilizing various Database Programming systems

Skills:

Competencies: 

• Ability to work independently, manage time and create plans to achieve project revenue and business goals
• Ability to work effectively with minimal direction; must be a self-motivated and self-directed individual who enjoys a challenging and dynamic work environment
• Team player willing to collaborate and share knowledge
• Highly organized
• Effective communication, interpersonal and negotiation skills
• Excellent organization and prioritization skills
• Exceptional customer service orientation and proven track record of successful client relationship management
• Conducts formal presentations to a wide variety of audiences including colleagues and clients with a high level of proficiency

#LI-AG2 #LI-REMOTE

We’re hiring a Clinical Trial Manager to help build and lead our expanding clinical operations across Latin America. This is an exciting, high‑impact opportunity based in Mexico, supporting rapid growth across Mexico, Brazil, Argentina, Colombia, Chile, and Peru.

As the clinical lead, you’ll own the planning, execution, and oversight of clinical studies, serving as the primary client contact and ensuring delivery in compliance with protocol, SOPs, ICH‑GCP, and regulatory requirements. You’ll shape country‑level recruitment strategies, lead feasibility and site start‑up, guide monitoring and quality strategies, and mentor CRAs and partners as we scale a new regional team.

This role offers significant career growth, including opportunities to build teams, define processes, influence culture, and step into broader leadership and project management responsibilities as the region grows.

Essential functions of the job include but are not limited to: 

• Primary clinical point of contact with the client
• Collaborate with PM on monthly invoicing and variance management of clinical budget
• Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) 
• Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings
• Generate potential site list from key stakeholders and drive site feasibility process
• Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment
• Develop and finalize the country recruitment/retention strategy 
• Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures 
• Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
• Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
• Support in planning and conducting investigator meetings
• Review and/or approve of IP release packages
• Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
• Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables 
• Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
• Responsible for eTMF implementation and management 
• Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure 
• Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
• Work closely with PM for project-specific resourcing issues
• Escalate pertinent CRA performance and site compliance issues when necessary
• Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
• Manage processes for investigational product (IP) including drug accountability and reconciliation 
• When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
• Support business development and marketing activities as appropriate 
• May negotiate site budget and investigator contract with support from the legal department and/or site contracts group
• May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
• May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
• May perform clinical data review of patient profiles, data listings and summary tables, including query generation
• May have line management responsibilities
• Performs other duties as assigned by management

Qualifications:

Minimum Required:

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
• Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience

Preferred:

• Advanced degree

Other Required:

• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) 
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Ability to travel domestically and internationally including overnight stays

Competencies: 

• Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement
• Working knowledge of clinical management techniques and tools
• Direct work experience in a cross-functional environment
• Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics 
• Proven experience in planning, risk management and change management
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
• Ability to lead and inspire excellence within a team
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Excellent presentation, verbal and written communications skills
• In depth proven experience in pharmaceutical and/or device research required
• Demonstrated successful independent negotiation and conflict management strategies 

#LI-AG2 #LI-REMOTE