Clinical Trial Manager

  • location: Cambridge, MA
  • type: Contract
  • salary: $55 - $62.56 per hour
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job description

Clinical Trial Manager

job summary:




  • Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.
  • In close collaboration with Clinical Operations Program Leads
  • Responsible for oversight of the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Company SOPs), on schedule and on budget.
  • Oversight of Strategic Partners and/or other CROs and other 3rd party vendors to meet Company's obligations described in ICH-GCP and Company's business objectives.
  • The assigned clinical studies may be high complexity or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.


 
location: Cambridge, Massachusetts
job type: Contract
salary: $55.00 - 62.56 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Accountable for planning and operational strategy for assigned clinical trials
  • Provides subject matter expertise and operational input into protocol synopsis and final protocol document
  • Challenges study team to ensure operational feasibility, inclusive of patient and site burden
  • Validates budget and ensures impacts are adequately addressed
  • Participates in country and site selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy
  • Challenges study team to ensure timelines meet the needs of the clinical development plan
  • With Strategic Partner(s) and/or other CROs, support the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place
  • Provide support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
  • Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s) , Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Leader(s) ; serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs
  • Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted;
  • Specific areas of sponsor oversight include, but are not limited to:
  • Review and approval of key risk based monitoring documents/plans, periodic review of outputs, decisions and actions related to risk based monitoring
  • Review and endorsement of Data Management Strategy and Operational Plan, a document which focuses on data concepts and data management principles at the study level
  • Study team (SET/CTWG) meeting attendance when necessary; regular review of meeting agendas and minutes
  • Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study
  • Documented review and monitoring of issues, risks and decisions at the study level
  • In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.
 
qualifications:
  • Education: Bachelor's Degree or international equivalent required, Life Sciences preferred.
  • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
  • Demonstrated excellence in project/program management and matrix leadership
  • Excellent teamwork, organizational, interpersonal, and problem-solving skills
  • Fluent business English (oral and written)
  • Experience: 5+ years' experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management strongly preferred. Experience must include early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.
  • Requires approximately 10-20 % travel, including overnight and international travel to other Company sites, strategic partners, and therapeutic area required travel.
 
skills: GCP (Good Clinical Practice)
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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