Clinical Operations Manager
Proclinical is currently recruiting for a Clinical Operations Manager with a biotechnology company located in Durham, NC.
- Partners with Medical Research and other functions to - Develop clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans
- Leverage appropriate on-going data review to identify and mitigate patient, study design, data or study conduct issues
- Ensure all operational aspects support end point integrity and data validity
- Develops and leverages Phase expertise (e.g. Phase I, II, III, IV), therapeutic knowledge, as well as internal and external data to develop protocols and experts operational strategy for one or more clinical studies
- Seeks interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phase
- Follows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model
Skills and Requirements:
- B.A. or B.S. in a scientific discipline; advanced degree preferred.
- At least 10 years of clinical research study management experience
- Prior CRO or investigator site and/or monitoring experience is a plus.
- Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV)
- Excellent project management skills, including risk assessment and contingency planning
- Prior CRO management skills and be able to adapt to the GCO outsourcing model.
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 267-297-3280.
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.