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Senior Manager Clinical Operation Lead
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 clinical studies 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 ongoing data review to identify and mitigate patient safety, study design, data integrity or study conduct issues
• Ensure all operational aspects support end point integrity and data validity.
• Able to influence MD on clinical study/program direction based on changing internal and external landscapes within phase, disease or therapeutic area; able to think strategically to best position a study within the current Clinical Development Plan.
Chairs SMT meetings and drives effective and efficient team operations through communication, goal setting and strategy implementation
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. 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.
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
• May also be responsible for contributing to a clinical development plan within a program moving into a new or subdivision of a current indication.
• Builds a rich knowledge of specific Area(s) of Expertise within a phase.
• Utilizes operational expertise and scientific assessment to evaluate study feasibility: assess end point measurement options, and ensure the successful execution of study(ies).
• Independently applies a deep understanding of the external landscape of a disease and associated drug development dependencies to influence the direction of the study.
• 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 Vendor Operations Relationship Manager for issue resolution
3. Strives for effective, consistent, efficient and compliant processes by:
• Champions 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 excellence in 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; provides feedback via appropriate channels for opportunities to improve processes or set best practices (i.e. PON)
• Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model.
• Is an advocate for the COL group and a visible contributor and vehicle to promote interaction
B.A. or B.Sc. in a scientific discipline; advanced degree preferred. Scientifically and clinically astute with very strong project management skills
Approximately 8 years of clinical research / project management experience preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline, and budget expectations. Prior investigator site and/or monitoring experience is advantageous
Deep understanding of clinical development within one or more Phases of trials (Phase II, III, IV) and a working understanding of cross functional drug development. Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas. 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. Must be able to build effective relationships across and up and down the organization.
• 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.
• Able to partner with other functions and both internal and external stakeholders. Excellent leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
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