This position is accountable for all aspects of assigned clinical trial(s) or compound level oversight. The position would manage staff assigned to the clinical trials to ensure consistency of operational implementation across the compounds. The workload of direct trialresponsible may depend on the workload and complexity of the trials. This position is also responsible for program level activities as assigned. Finally, this position is accountable for the day-to day clinical development operational plans in accordance with budget and timelines and with standard operating procedures (SOP), ICH Good Clinical Practices and any other specific country regulations.
- Accountable for development and execution of accurate operational Development plans, including assuring harmonization and high data quality across clinical trials/program.
- Assists in the development and writing of clinical Trials/program documents and manuals as appropriate
- Assists in the strategic oversight of the Clinical Research Organization (CRO) and other vendors
- Assists in the preparation of 'Requests for Proposal' documents and financial analysis of CRO proposal costs and negotiation
- Collaborates with Sr. Management, internal project team and CRO partners, as applicable, to prepare clinical trials/program timelines, budget and key deliverables consistent with departmental and corporate objectives
- Plans, implements and manages, in collaboration with CRO partners, Phase I-III clinical trials, as necessary
- Collaborates with Sr. Management to determine clinical supply requirements for clinical trials/program
- Assist for clinical program/trials implementation including operational feasibility, resource forecast and management across the compound
- Align the Clinical Trial Heads
- Clinical Trial Managers and CTS to resource the studies across the compound
- Provides updates and status reports to Sr. Management, as requested
- Contribute to the hiring plan and staffing activities including efficient on-boarding, training and mentoring of new employees.
- Maintaining close collaboration with clinical development , otherinternal departments and external vendors
- Maintain and develop Investigator sites and KOLs relationship
- Provide clear objectives, ongoing feedback and end of performance review for any direct report
- Bachelor of Science degree or a degree in a field relevant to a profession in biopharmaceutical industry
- Minimum of 7-8years’ experience working in project management and/or clinical operations within the biopharmaceutical industries and/or Clinical Research Organization (‘CRO’).
- Operational and direct managerial experience in the planning, executing and reporting of global clinical development trials
- Experience in program management preferred
- Must have experience in appropriate therapeutic area; preference in Oncology
- Proven ability to lead a multi-disciplinary teams
- Experience in developing effective relationships with key investigators.
- Good knowledge of GCPs, clinical trial design, statistics, regulatory processes, and drug development process.