The Clinical Trial Manager/Senior Clinical Trials Manager will be responsible for the operational management and oversight of clinical trials within a clinical development program. The position will work closely with the Medical Monitor and other cross-functional representatives including Clinical Data Management, Biostatistics, Regulatory/QA, Pharmacology and Biology to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. The position will also provide oversight of the CRO and other third-party vendors on the assigned study. This individual will report into the Head of Clinical Operations.
- Responsible for the planning, implementation and conduct of large, global, complex clinical trials in Phase I-IV; or multiple smaller early-phase studies.
- Responsible for oversight and project management of individual studies as well as relevant program related activities with minimal supervision.
- Provides leadership within the department and makes recommendations with regards to the operational aspects of executing clinical development deliverables.
- Actively provides operational direction and/or general supervision to direct reports
- Assist with training and mentoring of internal clinical operations staff.
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
- Manage CROs, vendors and consultants that are involved with the clinical trial and program.
- Track and report on progress of study including site activation, patient enrollment, monitoring visits
- Perform clinical data review of data listings and summary tables, including query generation
- Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
- Develop and maintain 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
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience)
- Investigate queries, monitor discrepancies
- Manage investigational product (IP) accountability and reconciliation process
- Responsible for review or approval of IP release packages
- Negotiate and manage the budget and payments for investigative sites
- Develop CRA and third-party vendor training on protocols and practices
- Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs as assigned.
- Write or contribute to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
- Perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work
- Bachelor’s degree or higher in a scientific or healthcare discipline preferred with minimum of 5-7 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, or CRO environment. Prior experience managing people is desired.
Knowledge, Skills and Abilities:
- Extensive experience managing clinical programs, CROs, budgets, and timelines required
- Proven experience in the oversight of the operational aspects of all stages of clinical studies
- Ability to organize and manage multiple priorities required
- Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Proactive and positive management approach
- Maximum flexibility to adapt to changing program needs in real time
- Strong leadership skills and self-awareness
- Ability to build strong relationships with co-workers of various backgrounds and expertise
We invite qualified candidates to submit their CV to: email@example.com (note: ‘Please put job title in subject heading)