GENERAL SUMMARY

4DMT seeks a motivated and detail-oriented In-House Clinical Research Associate (IHCRA) to support the Company’s clinical trial activities. This position reports to the Associate Director, Clinical Operations, and will support the day-to-day execution of a Phase 3 clinical trial, including study start-up, conduct, and close-out activities.

The IHCRA will serve as a key liaison between 4DMT, clinical sites, and CRO partners, with a focus on site support, monitoring oversight, regulatory compliance, and data quality. This role requires strong written and verbal communication skills, excellent organizational skills, and the ability to manage competing priorities while delivering high-quality work in a fast-paced, team-oriented environment.

MAJOR DUTIES & RESPONSIBILITIES:

Clinical Trial Operations & Site Support

• Support study execution across start-up, conduct, and close-out phases
• Serve as a primary point of contact for assigned clinical sites and CRO field CRAs/monitors
• Communicate directly with sites and CRO partners to obtain updates, resolve issues, and support study timelines
• Support site initiation, ongoing site management, and site close-out activities
• Assist with identification, documentation, tracking, and follow-up of site issues

 Monitoring Oversight

• Support oversight of CRO monitoring activities
• Review monitoring visit reports and follow up on action items and unresolved findings
• Track monitoring deliverables and escalate issues to the Associate Director, Clinical Operations as appropriate
• Support inspection readiness and audit activities

 Tracking & Study Oversight

• Maintain accurate tracking tools for assigned studies, including:
• Site start up and activation status
• Subject enrollment and visit status
• Essential document collection and TMF status
• Vendor reconciliation
• Assist with preparation of study status reports and metrics

 Regulatory Documentation & TMF Management

• Collect, review, and track site regulatory documents for completeness, accuracy, and compliance with applicable SOPs and regulatory requirements
• Ensure timely filing of documents in the TMF/eTMF in accordance with TMF plans
• Perform TMF quality control activities and support TMF audits and study close out

 Study Communications & Meetings

• Support organization and coordination of internal team meetings, investigator meetings, and other study related meetings
• Prepare meeting materials, take meeting minutes, and maintain action item logs
• Support communication of study updates to internal stakeholders

 Additional Responsibilities

• Support ad hoc Clinical Operations projects as assigned
• Willingness to travel as trial needs demand (<5% anticipated)
• Other duties as assigned, nothing in this position description restricts management’s right to assign or reassign duties and responsibilities to this position at any time 

QUALIFICATIONS: 

Education: 

• A. or B.S. degree required

Experience: 

• Minimum of 1-2 years of experience supporting clinical trials in a sponsor or CRO environment
• Experience supporting Phase 3 clinical trials preferred
• Ophthalmology Preferred

Other Qualifications/Skills: 

• Working knowledge of clinical trial operations and ICH GCP guidelines
• Experience with TMF/eTMF systems (Veeva Vault preferred)
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Strong organizational skills and attention to detail
• Ability to manage multiple priorities and meet deadlines
• Strong interpersonal skills and ability to collaborate effectively with cross functional teams and external partners

Travel: Willingness to travel as business needs demand (<5% anticipated)

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Compensation range: $38.00 TO 52.00  /HOURLY

Please note, the compensation range and actual rate offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 

GENERAL SUMMARY

4DMT seeks a motivated and detail-oriented In-House Clinical Research Associate (IHCRA) to support the Company’s clinical trial activities. This position reports to the Associate Director, Clinical Operations, and will support the day-to-day execution of a Phase 3 clinical trial, including study start-up, conduct, and close-out activities.

The IHCRA will serve as a key liaison between 4DMT, clinical sites, and CRO partners, with a focus on site support, monitoring oversight, regulatory compliance, and data quality. This role requires strong written and verbal communication skills, excellent organizational skills, and the ability to manage competing priorities while delivering high-quality work in a fast-paced, team-oriented environment.

MAJOR DUTIES & RESPONSIBILITIES:

Clinical Trial Operations & Site Support

• Support study execution across start-up, conduct, and close-out phases
• Serve as a primary point of contact for assigned clinical sites and CRO field CRAs/monitors
• Communicate directly with sites and CRO partners to obtain updates, resolve issues, and support study timelines
• Support site initiation, ongoing site management, and site close-out activities
• Assist with identification, documentation, tracking, and follow-up of site issues

 Monitoring Oversight

• Support oversight of CRO monitoring activities
• Review monitoring visit reports and follow up on action items and unresolved findings
• Track monitoring deliverables and escalate issues to the Associate Director, Clinical Operations as appropriate
• Support inspection readiness and audit activities

 Tracking & Study Oversight

• Maintain accurate tracking tools for assigned studies, including:
• Site start up and activation status
• Subject enrollment and visit status
• Essential document collection and TMF status
• Vendor reconciliation
• Assist with preparation of study status reports and metrics

 Regulatory Documentation & TMF Management

• Collect, review, and track site regulatory documents for completeness, accuracy, and compliance with applicable SOPs and regulatory requirements
• Ensure timely filing of documents in the TMF/eTMF in accordance with TMF plans
• Perform TMF quality control activities and support TMF audits and study close out

 Study Communications & Meetings

• Support organization and coordination of internal team meetings, investigator meetings, and other study related meetings
• Prepare meeting materials, take meeting minutes, and maintain action item logs
• Support communication of study updates to internal stakeholders

 Additional Responsibilities

• Support ad hoc Clinical Operations projects as assigned
• Willingness to travel as trial needs demand (<5% anticipated)
• Other duties as assigned, nothing in this position description restricts management’s right to assign or reassign duties and responsibilities to this position at any time 

QUALIFICATIONS: 

Education: 

• A. or B.S. degree required

Experience: 

• Minimum of 1-2 years of experience supporting clinical trials in a sponsor or CRO environment
• Experience supporting Phase 3 clinical trials preferred
• Ophthalmology Preferred

Other Qualifications/Skills: 

• Working knowledge of clinical trial operations and ICH GCP guidelines
• Experience with TMF/eTMF systems (Veeva Vault preferred)
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Strong organizational skills and attention to detail
• Ability to manage multiple priorities and meet deadlines
• Strong interpersonal skills and ability to collaborate effectively with cross functional teams and external partners

Travel: Willingness to travel as business needs demand (<5% anticipated)

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Compensation range: $38.00 TO 52.00  /HOURLY

Please note, the compensation range and actual rate offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 

GENERAL SUMMARY

4DMT seeks a motivated and detail-oriented In-House Unmasked Clinical Research Associate (uIHCRA) to support the Company’s clinical trial activities. This position reports to the Unmasked Clinical Trial Manager, Clinical Operations, and will support the day-to-day execution of a Phase 3 clinical trial, including study start-up, conduct, and close-out activities.  Role requires extensive experience in unmasked clinical settings. 

The uIHCRA will serve as a key liaison between 4DMT, clinical sites, and CRO partners, with a focus on site support, monitoring oversight, regulatory compliance, and data quality. This role requires strong written and verbal communication skills, excellent organizational skills, and the ability to manage competing priorities while delivering high-quality work in a fast-paced, team-oriented environment.

MAJOR DUTIES & RESPONSIBILITIES:

Clinical Trial Operations & Site Support

• Support study execution across start-up, conduct, and close-out phases
• Serve as a primary unmasked sponsor point of contact for unmasked clinical site staff in collaboration with CRO field unmasked CRAs/monitors
• Communicate directly with unmasked site staff and unmasked CRO partners to obtain updates, resolve issues, and support study timelines
• Support site initiation, ongoing site management, and site close-out activities
• Assist with identification, documentation, tracking, and follow-up of site issues

Monitoring Oversight

• Support oversight of unmasked CRO monitoring activities
• Review unmasked monitoring visit reports and follow up on action items and unresolved findings
• Track monitoring deliverables and escalate issues to the Unmasked Clinical Trial Manager, Clinical Operations as appropriate
• Support inspection readiness and audit activities

Tracking & Study Oversight

• Maintain accurate tracking tools for assigned studies, including:
  • Site start up and activation status
  • Initial IP supply and Ancillary supply
  • Site visit activities
  • IP Shipment status and delivery
  • Assist with preparation of study status reports and metrics

Regulatory Documentation & TMF Management

• Collect, review, and track site applicable SOPs
• Ensure timely filing of unmasked documents in the TMF/eTMF in accordance with TMF plans
• Perform TMF quality control activities and support TMF audits and study close out
• Support the review of Quality Incidents and follow up activities

Study Communications & Meetings

• Support organization and coordination of internal team meetings, and other study related meetings
• Prepare meeting materials, take meeting minutes, and maintain action item logs
• Support communication of study updates to internal stakeholders

Additional Responsibilities

• Support ad hoc Clinical Operations projects as assigned
• Willingness to travel as trial needs demand (<15% anticipated)
• Other duties as assigned, nothing in this position description restricts management’s right to assign or reassign duties and responsibilities to this position at any time 

QUALIFICATIONS: 

Education: 

• A. or B.S. degree required

Experience: 

• Minimum of 1-2 years of experience supporting clinical trials in a sponsor or CRO environment on the unmasked side
• Experience supporting Phase 3 clinical trials preferred
• Ophthalmology Preferred

Other Qualifications/Skills: 

• Working knowledge of clinical trial operations and ICH GCP guidelines
• Experience with TMF/eTMF systems (Veeva Vault preferred)
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Strong organizational skills and attention to detail
• Ability to manage multiple priorities and meet deadlines
• Strong interpersonal skills and ability to collaborate effectively with cross functional teams and external partners

Travel: Willingness to travel as business needs demand (<15% anticipated)

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Compensation range: $38.00 TO 52.00 /HOURLY

Please note, the compensation range and actual rate offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 

GENERAL SUMMARY: 
The Clinical Trial Manager will support the Company's clinical trial activities.  This position reports to the Director of Clinical Operations.  This will be responsible for management of the day to day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close out activities.  This is a 6 month contract remote opportunity.    
 
MAJOR DUTIES & RESPONSIBILITIES: 

Trial Management:  

• Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial 

• Lead cross-functional study execution team in support of study deliverables 

• Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership 

• Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs 

• Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents 

• Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews 

• Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files 

• Participates in service provider selection process as a part of outsourcing activities 

• Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and resolution of project issues and participates in process improvement initiatives as required 

• Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of Clinical Operations 

• Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers 

• In conjunction with legal  group,  facilitate  the  development  of  clinical  trial agreements and other relevant documents 

• Manage clinical trial budgets, providing ongoing financial reporting and projections 

• Negotiate and finalize site contracts and budgets 

• Perform and manage data review process on an ongoing basis 

• Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed 

• Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues 

• Ensures tracking and review of protocol deviations and assesses impact on study data 

• Develops and manages study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget 

• Provides oversight for forecasting of clinical supplies, including study drug and supplies 

 Department Management:  

• May manage and/or oversee work of junior Clinical Operations staff 

• May support development and review of Clinical SOPs and other department initiatives 

• Travel as needed to sites, conferences, industry meetings 

• Other duties as may be assigned 

 
QUALIFICATIONS: 

Education: 

• B.A./B.S. degree 

 Experience: 

• 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management 

 Other Qualifications/Skills: 

(non-technical and technical skills) 

• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management; Strong clinical study management skills 

• Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners 

• Proven clinical operational skills to direct protocol execution to ensure timeline, budget and quality metrics are met 

• Excellent communication skills to effectively disseminate information to project team and outside parties 

• Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management 

• Clinical research knowledge and cross-functional understanding of clinical trial methodology 

• Excellent organizational, conflict resolution, prioritization and negotiation skills   

• Proven ability in creative problem-solving and exercising sound judgment 

• Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners 

• Ability to handle a high volume of highly complex tasks within a given timeline 

• Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance 

• Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook 

• Working knowledge of MS Project for development and update of clinical study timelines 

 Travel: 5% 

Physical Requirements and Working Conditions: 

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word. 

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. 

• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). 

HR ONLY: Hourly Compensation Range: $84.00 - 94.00

Please note, the compensation range and actual rate offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.  

GENERAL SUMMARY:   

The Associate Director, Clinical Operations will be responsible for implementation, execution and oversight of all clinical trials within a clinical program, in coordination with cross-functional project teams to ensure that assigned clinical trials are executed on time, within budget, and in compliance with GCP and other applicable guidelines and regulations.   

 MAJOR DUTIES & RESPONSIBILITIES:  

• Partner with Director of Clinical Operations to develop and manage clinical programs in compliance with corporate objectives and timelines  

• Provide operational leadership to the direction, planning, execution and interpretation of clinical trials and data collection by effectively developing and monitoring clinical trial/program timelines, budgets, risks and mitigation plans   

• Provides guidance and mentoring to Clinical Trial Managers (CTMs) and junior level team members in study document development, vendor and study management, study implementation, issue resolution, timelines, budgeting and resourcing  

• Independently oversee day-to-day activities of the Clinical Trial Operations and Clinical Data Management groups  

• Collaborate with Finance/Business Operations on annual budget planning (external spend) as well as quarterly budget reviews and re-forecasts; designing, implementing, and overseeing clinical vendor outsourcing strategy; actively participating in the selection of vendors to support 4DMT clinical trials as well as active governance of them; participating and/or leading vendor governance committees  

• Ensure that each clinical trial is always inspection ready  

• Ensure that each clinical trial is being actively managed by a cross-functional Study Execution Team (SET)  

• May sit on product cross-functional core teams as Clinical Operations SME  

• Partner closely with Quality to ensure that the programs and 4DMT always remain inspection ready  

• Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (e.g., Clincialtrials.gov)  

• Addresses escalated study issues in collaboration with CTMs and senior management as appropriate inclusive of risk mitigation plans  

• Coordinates the development and maintenance of clinical SOPs as pertains to the program and provides review/ input into cross-functional SOPs and other documents  

• Supports development and review of protocols/ amendments, study documents and plans, and operational execution  

• Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate  

• Contributes to the development of the Clinical Operations department processes and procedures and will manage clinical resources to ensure effective implementation of trials.  

  QUALIFICATIONS:   

 Education:  

• B.S./B.A. in Life Science or related discipline required  

• Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred 

• Clinical Research certification preferred, but not required 

 Experience:   

• B.S./B.A. with 9+ years of industry experience in clinical development with a minimum of 3 years managerial experience, or M.A./M.S. with 4+ years of experience 

• Requires 1+ years ophthalmology trial experience as well as late phase trial experience.  Relevant experience in clinical trial execution across all phases  

 Other Qualifications/Skills:   

• Proven ability to recruit, retain, organize, and motivate clinical operations personnel  

• Ability to communicate to Clinical Operations and Development Leadership team updates and priorities as well as to advocate for required budget and resources  

• Ability to manage and oversee programs that have corporate-wide impact  

• Ability to develop and manage functional and clinical trial-specific budgets  

• Must be self-motivating; prioritize and manage a large volume of work; show attention to detail  

• Strong interpersonal skills are essential as this individual will partner with various team members and functional groups for clinical trials and business performance  

• Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials  

• Ability to be flexible and adaptable to changing business needs  

• Excellent communication and interpersonal skills  

• Must be able to write clearly and summarize information effectively  

• Must be able to present complex information to various audiences  

 Travel: Anticipate 20%, or as trial needs demand 

 Physical Requirements and Working Conditions: 

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word. 

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. 

• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $180,000 - 200,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.  

GENERAL SUMMARY:
The Clinical Trial Manager will support the Company's clinical trial activities.  This position reports to the Director of Clinical Operations.  This will be responsible for management of the day to day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close out activities.  

MAJOR DUTIES & RESPONSIBILITIES:

Trial Management:

• Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial
• Lead cross-functional study execution team in support of study deliverables
• Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership
• Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
• Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents
• Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
• Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files
• Participates in service provider selection process as a part of outsourcing activities
• Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and resolution of project issues and participates in process improvement initiatives as required
• Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of Clinical Operations
• Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
• In conjunction with legal  group,  facilitate  the  development  of  clinical  trial agreements and other relevant documents
• Manage clinical trial budgets, providing ongoing financial reporting and projections
• Negotiate and finalize site contracts and budgets
• Perform and manage data review process on an ongoing basis
• Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed
• Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues
• Ensures tracking and review of protocol deviations and assesses impact on study data
• Develops and manages study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget
• Provides oversight for forecasting of clinical supplies, including study drug and supplies

 Department Management:

• May manage and/or oversee work of junior Clinical Operations staff
• May support development and review of Clinical SOPs and other department initiatives
• Travel as needed to sites, conferences, industry meetings
• Other duties as may be assigned

QUALIFICATIONS:

Education:

• B.A./B.S. degree

Experience:

• 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management

Other Qualifications/Skills:

(non-technical and technical skills)

• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management; Strong clinical study management skills
• Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners
• Proven clinical operational skills to direct protocol execution to ensure timeline, budget and quality metrics are met
• Excellent communication skills to effectively disseminate information to project team and outside parties
• Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
• Clinical research knowledge and cross-functional understanding of clinical trial methodology
• Excellent organizational, conflict resolution, prioritization and negotiation skills  
• Proven ability in creative problem-solving and exercising sound judgment
• Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
• Ability to handle a high volume of highly complex tasks within a given timeline
• Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance
• Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
• Working knowledge of MS Project for development and update of clinical study timelines

Travel: 5%

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $150,000 - 172,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.