Clinical Operation Lead
Proclinical is currently recruiting for a REMOTE Clinical Operation Lead with a biotechnology company.
- Lead Study Management Team (SMT) meetings and cross-functional coordination and alignment.
- Ensure all study forms and materials are developed according to the governing SOPs.
- Align with the SMT the team goals, deliverables, timelines and ensure these are on track or met.
- Vendor management and oversight (including CRO): selection, contracting, raising PO, tracking budget, performance/metrics/KPIs and attend vendor meetings.
- Support CRO with site contract execution- liaise with Legal when required and perform site budget oversight.
- Full study budget tracking and forecast projecting. Liaise and report back to Finance Business partner.
- Oversee the study filing systems (ie: sharepoint, trial master file) and ensure proper filing performing Quality checks as needed.
- Support with Study Approval governance and system. Ensure study data is accurate and updated on an ongoing basis in the system.
- Oversee the trial coordinator associate assigned to the studies for administrative support (ie: scheduling meetings, taking minutes)
- Serves as liaison between and coordinate SMT (including Affiliates and field MSLs) and sites and/or any Third-party vendors.
- Performs risk management and identifies and proactively raises issues to the SMT as appropriate, prior to their becoming critical. Maintains corresponding study logs.
Skills and Requirements:
- Familiar with Sharepoint, CTMS, MS project (Planview/Plansource), RAVE EDC, ePROs, eTMF.
If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.