MSI Pharma are seeking to fill a position for a Top Biotech Organisation based in the West Coast. The client is looking for Clinical Study Managers who will lead all aspects of assigned clinical trials and demonstrate a high level of knowledge of clinical operations.
- Works to ensure adherence to a standardized approach to clinical trial management
- Manages clinical trial projects through leadership of and delegation to a cross-functional study execution team (CST), working under the guidance and direction of the Clinical Program Lead. Ensures successful clinical trial planning, execution and delivery - within specified quality, time and cost parameters
- Exhibits a strong understanding of methodologies and approaches, ensures alignment of clinical project goals with Clinical Operations program objectives
- People management which includes performance oversight and development, quarterly check-ins and year-end performance reviews
- Mentoring of team members
- Ensures that TMF for assigned clinical trial(s) is created, maintained, monitored, and closed out on a timely basis
- Ensures site monitoring reports are accurate and thorough, reviewed on a regular basis and that metrics are being adhered to
- Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance
- Manages Central Lab and ancillary vendors selection, set-up, conduct, and close-out for studies.
- Oversees and/or delegates the management and oversight of study vendors (CRO) to ensure that clinical trials are getting the necessary resources and attention the vendor has committed to, ensures trial deliverables and performance goals are met.
- Adheres to and contributes to the development and review of Clinical Operations Work Instructions and SOPs
- Escalation point person to Clinical Program Lead and Program Management Lead when necessary.
- Oversees the development of and adherence to clinical trial project timelines and ensures senior Clin Ops staff, DCT, and line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
- Bachelor's degree or higher in a scientific or healthcare discipline preferred.
- 3-5 years of progressive experience in clinical research or clinical operations within the biotech, pharmaceutical sector or CRO industry.
- Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required.
- Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required.
- Management experience of CROs, Vendors and Consultants preferred.
- Therapeutic or medical knowledge preferred