Clinical Trial Manager

  • location: Cambridge, MA
  • type: Contract
  • salary: $85 - $90.97 per hour
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job description

Clinical Trial Manager

job summary:
  • Responsible for the oversight, conduct, and ongoing management of vendors for assigned clinical trials.
  • Provide oversight of clinical study(ies) in compliance with procedural documents, SOPs, Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, and all applicable regulations within the Clinical Development Plan (CDP) and according to the VBU operating model.
  • Leadership of the cross functional Study Execution Team (SET), to ensure study objectives and KPIs are met with expected quality, on schedule and on budget.
  • Responsible for continuous monitoring of KPIs and Metrics compliance, study specific risks and mitigation solutions, timelines & budget for assigned studies.
  • Responsible for providing study level updates and summaries to the Program Operational Oversight Lead (POOL) ensuring that any study issues, with proposed solutions, are escalated as appropriate.
  • Management of the study budget, including Task Orders, Change Orders, invoice approval and financial reconciliation process.
  • The assigned clinical study/studies will be global or multinational, requiring multi-functional leadership experience and skills to achieve study goals.
 
location: Cambridge, Massachusetts
job type: Contract
salary: $85.00 - 90.97 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Accountable for delivery of assigned clinical study(ies) in compliance with procedural documents, SOPs, Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, and all applicable regulations within the Clinical Development Plan (CDP) and according to the VBU operating model.
  • Responsible for the roll-out and maintenance in assigned clinical studies of risk-management approach defined for program.
  • In alignment with the applicable operating model, lead the cross functional SET in close collaboration with the CRO, providing oversight to ensure study goals and KPIs are met, with expected quality on schedule and on budget.
  • Contribute to protocol and/or synopsis, as well as the Clinical Study Report development.
  • Lead the evaluation and selection of required vendors based on confirmed study assumptions, supporting contract and budget negotiation, approving invoices and performing financial budget reconciliation.
  • Responsible for day-to-day oversight and management of vendors working on assigned study, including setting expectations, training, managing timelines and deliverables, and issue management. If requested, provide input to other important study activities, including but not limited to: site identification, feasibility and selection, enrolment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock.
  • Escalate medical issues to appropriate medical personnel.
  • Track and manage trial specific budget and milestones incl. tracking and verification of invoices and update of plans/systems (CTMS, Meridian, etc.); provides regular budget updates to POOL and/or Finance when required.
  • In collaboration with Study Execution Team (Company functions, Strategic Partners, and vendors), identify risks to study and develop risk mitigation plans, including communication and collaboration with POOL to escalate risks and ensure rigorous risk mitigation planning.
  • Responsible as Company first point of contact for Issue Management process for assigned study.
  • Company primary point of contact for CRO Project Lead.
  • Can act as a Regional oversight lead in case of complex, multi-country trials.
  • Identify need for specific trainings with impact in the conduct or execution of the trial and ensures they have been provided.
 
qualifications:
  • B.S. degree in related discipline, preferably in life science, or equivalent. Advanced degree highly desirable
  • At least 5 years experience in clinical study/program management experience in the pharmaceutical industry including CRO experience. Experience in vaccine clinical study/program management highly desirable
  • At least 3 years experience of matrix management/ team experience, and show strong leadership
  • Knowledge of drug development process and related GxP activities
  • Strong expertise in clinical study delivery and oversight
  • Knowledge of local and international regulations and guidelines
  • Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes) desirable
  • Prior exposure to complex matrix environments requiring the use of influence and persuasion skills without authority
  • Ability to work in a virtual team environment
  • Good analytical, problem solving, negotiation and conflict resolution skills
  • Excellent written and verbal communication skills with fluent business English
  • Ability to sit and stand for long periods of time
  • Carrying, handling and reaching for objects
  • Ability to lift and carry over 25 pounds
  • Manual dexterity to operate office equipment, i.e. computers, phones, etc
  • TRAVEL REQUIREMENTS:

    • 15-20% international travel required
 
skills: CTMS (Clinical Trial Management Systems)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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