This pharmaceutical organization develops therapies to tackle cancer and other serious diseases.
Title: Clinical Operations Project Manager — JO-2202-5735
Therapeutic Area: Oncology
The Project Manager plans, executes, and reports on clinical studies, including oversight of performance and quality standards on assigned trials to ensure delivery on time, on budget, and in compliance with Company processes, KPIs, quality standards, and local regulatory requirements. The position is key to streamlining communication with internal and external stakeholders.
Reports to Head of Clinical Operations.
Essential Duties and Responsibilities
- Responsible for end-to-end management of trials as assigned from planning through to study close-out.
- Manage 3rd party vendors as required.
- Work closely with relevant team members to develop/review essential trial documentation, including but not limited to the clinical study protocol, monitoring plan, protocol deviation plan, communication plan to ensure compliance with Clarity SOPs.
- Facilitate preparation and collection of study-related documents; resolve problems as required.
- Drive the conduct of the trial, track and oversee progress and status, including but not limited to study startup, monitoring frequency, prompt site issue resolution, TMF maintenance, drug supply management.
- Appropriately escalates issues in a timely manner and ensures resolution.
- Lead and chair study team meetings.
- Track trial budget with Head of Clinical Operations ensuring study budgets are adhered to.
- Track Vendors and/or internal Study Management Team performance against deliverables, contracts, and timelines.
- Consistently read/review the content of all monitoring visit reports for the assigned trial to identify trends and issues.
- Manage data at the third-party/site level (as applicable); resolve technical and content issues to achieve aggressive database lock targets.
- Ensure regular SAE database reconciliation is performed with clinical databases.
- Ensure that all trial closeout activities are performed, in close cooperation with field monitors and 3rd party vendors.
- Oversee local vendor selection and performance as needed.
- Serve as the main contact for any potentially significant quality/compliance issues and escalate to Head of Clinical Operations as required.
- Mentor/coach CRAs as needed to ensure trial success. This may involve co-monitoring visits with site CRAs. May act as a study CRA to meet company needs.
- Support the Head of Clinical Operations in the development and maintenance of clinical SOPs & trial process.
- Build a positive culture within clinical operations and cross-functionally.
Qualifications (Education & Experience)
- Degree in scientific or healthcare discipline.
- Ideally 7+ years of pharmaceutical industry experience with 5 years of strong experience in clinical research.
- Experience in a monitor role or a role overseeing clinical trials.
- Strong project management skills.
- Excellent verbal and written communication skills.
- Highly proficient in negotiation skills.
- Ability to work under pressure.
Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Affairs, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.