Sr. Clinical Trial Manager / Associate Director (level commensurate with experience) (Contractor)
Department: Clinical Operations
Reports to: Sr. Director, Clinical Operations
Trishula seeks an experienced, highly motivated Clinical Trial Manager to provide operational management and oversight of clinical trials within a clinical development program. This individual will be responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. Additionally, the Clinical Trial Manager will provide oversight of the CRO and other third-party vendors on assigned study(ies). The Clinical Trial Manager will work closely with Trishula cross-functional team lead and will report into the Sr. Director of Clinical Operations.
Principal Accountabilities and Responsibilities:
- Provide CRO oversight on day-to-day operations and responsible for CRA and third-party vendor training on protocols and practices
- Develop and maintaining good working relationships with 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
- Identify, select, and monitor performance of investigational sites for clinical studies
- Investigate queries, monitoring discrepancies
- Manage IRT vendor and IP projection and work with CRO on investigational product (IP) accountability and reconciliation process
- Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to Director of Clinical Operations
- Perform clinical data review of data listings and summary tables, including query generation
- Support Director of Clinical Operations to provide program updates to internal team, BOD and partner.
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team
- Review or approve of IP release packages
- Oversee CRO/consultants on eTMF maintenance
- Track and report on progress of study including site activation, patient enrollment, monitoring visits
- Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
- Responsible for internal contracts routing approval
- Bachelor’s degree or higher, or equivalent combination of education/experience in, science or health-related field required
Minimum 5 years of trial management experience and 8+ years of clinical trial experience in Pharmaceutical, Biotech, or a CRO company is required
Working knowledge of GCP/ICH guidelines and the clinical development process
Please send your CV/resume to firstname.lastname@example.org.