Clinical Operations Lead

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Required:

•Strong Early Phase experience, preferably in Phase O or the Scientific Research Collaboration area •Creative thinking to solicit support for the varying aspects of the studies

•Early clinical research experience (basic research experience is a plus, but not a requirement)

•In-depth understanding of the regulatory and ethical environment across countries and regions for IMP and NIMP studies

•Ability to scientifically understand protocols and provide input on all operational aspects in order to inform the development of an effective operational strategy

•Ability to quickly adapt to flexible clinical processes, emerging science, and new evolving trial methodologies

•Ability to adapt to a flexible frame of work and comfortable with the unknown

Individuals with very strong Early Phase experience, preferably in Phase O or the Scientific Research Collaboration area, with a view to this person joining the current group to take on study work in this expanding area. The key here is individuals who are reactive, knowledgeable within Early Phase space and able to work as part of a team to achieve best results.” Job Description: Partners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols. Leverage Phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level strategy. Independently oversees one or more trials by establishing the operational strategy and securing excellence in execution through the CRO partner. 1. 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. Has a robust understanding of the study design including rationale, end points and patient population, and will ensure that the operational strategy supports both feasibility and scientific integrity. Leverages Phase expertise (e.g. Phase I, II, III, IV), therapeutic knowledge, as well as internal and external data to develop protocols and expert operational strategy for one or more clinical studies. 2. 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 3. 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.