Senior Clinical Trial Manager
Contract to hire Role
Job Summary:
The Senior Clinical Trial Manager will play a key contributor role in the implementation and execution of clinical trial(s) from study start up to close-out. The incumbent will have responsibilities for the management and oversight of CRO's, study vendors and clinical trial sites, and will partner key internal stakeholders to ensure clinical trial deliverables are completed on-time, within budget, and in accordance with regulatory requirements, GCP guidelines and internal SOP's.
Key Responsibilities:
- Develop and maintain good working relationships with CRO, investigators and study staff.
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
- Ensure timely response to queries and monitoring discrepancies.
- Assist with third-party vendor training on protocols and practices.
- Track and report on current progress of the study including site activation, patient enrollment, monitoring visits and data entry backlogs.
- Support the investigational product (IP) study drug accountability and reconciliation process.
- Oversee the performance of CROs and third-party vendors, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Managers.
- Perform clinical data review of data listings and summary tables, including query generation.
- Perform initial review of CRO and other third-party study vendor invoices for correctness.
- Review and/or approve IP release packages.
- Contribute to the preparation of clinical protocols, amendments, informed consent forms, study manuals and guides, electronic case report forms, and any other clinical research related documents.
- Participate in the planning of quality assurance activities, coordinating the resolution of applicable audit findings.
- Ensure audit-ready condition of clinical trial documentation including clinical trial master files; review monitoring visit reports to ensure quality and resolution of site-related issues; coordinate and assist in the planning of regulatory or ethics committee activities, as appropriate.
- Collaborate with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CRO, vendors and Investigators/site staff).
- Prepare and/or review study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.).
- Prepare/review site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
- Manage clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.) ensuring compliance with ICH/GCP and applicable regulations, including the management through resolution (e.g. CAPA) of any site or study level issues, deviations, etc.
- Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
- Perform other duties as assigned by supervisor.
Qualifications:
- Undergraduate degree in life sciences or relevant work experience. Graduate degree preferred.
- Therapeutic experience in oncology is strongly preferred.
- Minimum 5 years experience managing clinical trials, with at least 2 years on the sponsor side
- Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding drug development and data management methods.
- Experience monitoring sites and conducting other site management activities.
- Proven experience in early phase clinical trials.
- Strong site management and CRO management skills required.
- Outstanding communicator, both oral and written.
