Clinical Operations Lead III--Cambridge, MA
Clinical Operations Lead III
- Partners with Medical Research and other functions to:
- Develop scientifically robust, operationally feasible and 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.
- Secures operational excellence and delivery for one or more clinical studies by:
- Developing operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country Lead * Overseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRO * Driving performance, quality, timelines and relationships through the CRO partnership model * Chairs the [Study Management Team] in partnership with the CRO study Lead of the [Study Management Team]; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues.
- Partnering with GCO Vendor Management to escalate issues, sharing best practices and leveraging the relevant vendor management member for issue resolution
- Strives for effective, consistent, efficient and compliant processes by:
- Championing best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group * 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 * Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership model.
- 4-5 years of Clinical Trial 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)
- A working understanding of cross functional drug development
- Ability to establish operational plans and support the CRO in the execution of the plans
- Requires a balance of scientific and operational/project management and team leadership expertise
- Excellent project management skills, including risk assessment and contingency planning
- Must have effective prior CRO management skills and be able to adapt to the GCO outsourcing model.
If you or someone you know is interested in this position, please submit a resume to Isabella Martin i.martin (at sign)realstaffing.com.
Sthree US is acting as an Employment Agency in relation to this vacancy.