Our Client is looking for a Director of Clinical Operations who will be responsible for successfully leading all clinical operational aspects of phase II and III global clinical trials and has expertise in multiple therapeutic areas and specific expertise in Central Nervous System indications. This candidate will provide clinical operations strategy, planning, initiation, and execution of clinical trials, including vendor selection, contracts and budgets, vendor oversight and management, and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance. Responsibilities also include leading and assisting with creation of essential project documents, such as protocols, CRFs, ICFs, operation manuals, monitoring plans, SOPs, development plans, safety updates, and clinical study reports.
- Help with CRO selection process, including negotiating proposals and determining deliverables.
- Primary contact for CRO Clinical Trial Manager, Project Manager. Back-up contact for site personnel if site personnel are unable to contact CRO.
- Internal lead on weekly CRO/Internal team communications and progress reports. Coordinate discussions regarding project risks and strategies with CROs, including but not limited to recruitment, site issues, etc. Participate in meetings with CRO Executive Team when required.
- Primary contact for CRO legal and Internal legal for Clinical Trial Agreement negotiation/ escalation and for Letter of Indemnification negotiation/escalation.
- Primary contact for CRO study start-up team for clinical site budget escalation.
- Review CRO invoices against statement of work and ensure accuracy. Review CRO trip reports and seek clarifications on monitoring issues.
- Will provide clinical content input to: • Regulatory interactions and documents. • Safety interactions and documents. • Will communicate directly with senior management regarding progress of clinical programs.
- Clinical Operations
- Phase II / III Exp
- CRO Selection / Management
- Cross Functional Exp
- Independent / Hands on background
- CNS – Plus
Location: Bridgewater, NJ ( 2-3 days onsite a week / rest remote)
Start Date: 11/28
Duration: 6 Months +
Education: Experience over Degree
Hybrid/NJ: Director, Clinical Operations (232074)