Clinical Supplies Specialist- San Diego, CA
Job Summary: The Senior Director, Clinical Operations will oversee the operational aspects of Phase 1 to Phase 3 clinical studies. This person will lead the study team and will support study planning, study conduct, and reporting. He/she should have the experience to implement best practices and ensure studies are conducted according to the approved budgets and timelines. The Senior Director, Clinical Operations will help implement improved clinical operations processes at MEI. He/she will interact internally with executive management and with participating clinical investigators. The Senior Director, Clinical Operations will supervise and mentor study managers and other members of the MEI Clinical Operations team.
Role & Responsibilities:
- Develop timelines for planned clinical trials and support feasibility efforts and country/site selection.
- Develop clinical program budgets and liaise with Finance/Accounting in communicating budget forecasting and accruals.
- Develop Request for Proposals (RFPs) and define scope of services for outsourced clinical activities.
- Oversee CRO/vendor selection process activities, seeking input from other internal functional groups.
- Ensure qualification of CROs, vendors and service providers in accordance with MEI Pharma’s SOPs.
- Manage CRO/vendor agreements, ensuring change orders and budgets meet defined clinical operations specifications.
- Review protocols, informed consents and CRFs and track development to completion.
- Review proposed site contract/agreement templates and budget templates.
- Supervise the negotiation of investigator agreements and grants appropriate to the clinical. programs. Will review and approve any variations to the proposed agreement and/or grant.
- Review protocol deviations and evaluate trends across studies.
- Ensure clinical data are collected and managed in accordance with the study monitoring plan and data quality standards.
- Ability to collaborate, negotiate and manage competing priorities across multiple functional areas.
- Ensure all functional groups provide deliverables (i.e., query generation and resolution, data base lock, study report). Inform all groups of deliverables and timeline, project developments and ensure completion according to timelines.
- Contribute to the clinical content of Investigator’s Brochure (IB), Development Safety Update Report (DSUR), etc.
- Prepare high-quality reports for management on program status and issues.
- Recommend and assist in implementing innovative process ideas that positively impact clinical trials and/or clinical program management.
- Ensure clinical trials are conducted in compliance with applicable ICH-GCP guidelines, SOPs and local regulatory guidelines or regulations.
- Report any potential GCP violations, either internally or externally, to the Head of Clinical Operations and participate in any corrective and preventative action (CAPA) plans as appropriate.
- Participate in the development and review of departmental SOPs and working practices.
- Work independently, exercise appropriate judgment and coach other team members for effective communication.
- Line management of one or more study managers, internal CRA and/or clinical operations associate.
- Bachelor’s degree, RN or equivalent with a minimum of 10 years of experience in clinical operations.
- Experience managing large, global clinical trials. Oncology experience strongly preferred.
- Experience with inspection readiness and experience supporting NDAs or BLAs preferred.
- Ability to communicate, verbal, analytical and organizational skills, project management, management, and computer expertise.
- Possess a strong commitment to quality and accuracy.
- A self-starter and a team-player who thrives in a fast-paced environment.
- Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
- Regular communication (hearing/speaking).
- Lifting up to 25 lbs.
- Routine office duties including computer keyboard use.
- Vision requirements include close vision and ability to focus.
- Noise conditions range from quiet to moderate.