| This position is responsible for the overall management of clinical studies in multiple Phases including, but not limited to, the development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filing. He or she ensures effective communication across the functional groups, during all stages of the clinical studies, to ensure completion of study deliverables on time and on budget. This position requires a detailed understanding of overall strategic direction; interrelationships and business needs. |
- Manages all clinical aspects of study, including: assesses operational feasibility and recommends study execution plan; develops and manages comprehensive study timelines and metrics; participates in selection and management/oversight of external vendors; reviews vendor reports, budgets, and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel; prepares and presents project debriefings, as required; plans, executes, and leads study-specific meetings (e.g., Study Management Meetings, investigator meetings, Advisory Committee).
- Uses operational and therapeutic expertise to optimize trial design and execution; works with the study team to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; prepares study-related documentation; provides input for the design of the ICF template, CRFs, monitoring conventions, edit checks, etc.
- Prepares and/or reviews study-related documents (e.g., Study Operations Plan, Monitoring Plan, Laboratory Manual, CRF Completion Guidelines, and other study-specific documents or manuals).
- Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
- Selects sites and countries; develops relationships with investigators and site staff.
- Develops and manages study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budget.
- Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs/SWPs; participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as
- Daily interaction with study Medical Director and members of the cross-functional study team; leads the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.).
- Contribute to individual and team development through training initiatives and team building activities.