The Clinical Trials Manager coordinates the activities associated with the evaluation, initiation, and management of solid tumor oncology clinical trials.
Requirements
- Manages clinical trials, including those conducted through Contract Research Organizations (CROs)
- May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams
- Responsible for at least one geographical region and manages/oversees one to three external vendors within a specific scope (e.g., Lab)
- Engages with CROs, vendors and sites for ongoing trial execution, including relationship management and quality / performance oversight
- Provides CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc.
- Attends and contributes to internal Study Delivery Team (SDT) meetings, including contribution to agenda preparation
- Coordinates the preparation, conduct, and presentations at Investigator Meetings
- Assists Study Delivery Team (SDT) and CRO in feasibility assessments and site selection
- Assists with study protocol development, reviewing of informed consent forms, case report forms, monitoring plans, and other study materials
- Maintains regular contact with relevant departments (e.g., Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.)
- Provides oversight to CRO to ensure site adherence to protocol and Good Clinical Practice (GCP) guidelines
- Proactively identifies and communicates study issues, provides risk mitigation strategies, and escalates issues as needed
- Provides support for adherence/compliance to study plans (e.g., Verification of Performance (VOP))
- Ensures oversight of regulatory and essential documents
- Supports and oversees the development of study plans and documents (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals)
- Coordinates the design, format, and content of study guides and subject instructions
- May participate in strategic governance discussions as required (e.g., SAB, BOD, DT, TAT, DSC, DOC)
- May support / be responsible for site and vendor invoice reviews
- Reviews and provides oversight of study trackers and metrics
- Provides oversight to development and review of study documents (i.e. Protocol, ICF, CRFs, IRT specifications, Inv product labels, etc)
- May be responsible for department strategic initiatives or process improvements
- May serve as a mentor and provide training to Sr. Clinical Trial Specialists (CTS)
Benefits
- 401k plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- discretionary annual bonus program
- sales-based incentive plan
- opportunity to purchase company stock
- long-term incentives
- 15 accrued vacation days in their first year
- 17 paid holidays including a company-wide winter shutdown in December
- up to 10 sick days throughout the calendar year
