Sr Manager, Clinical Operations Lead

Job Description

As a Sr Manager, Clinical Operations Lead, you will partner with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols. You will leverage phase and operational expertise to establish study level operational strategy and alignment with the Clinical Development Plan (CDP) and program level strategy.

You will also independently oversee one or more clinical studies by establishing the operational strategy and securing excellence in execution through the CRO partner.

1. Partner 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 safety, study design, data integrity or study conduct issues
• Ensure all operational aspects support end point integrity and data validity.
• 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.
• Chair 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. Secure 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
• Contributing to a clinical development plan within a program moving into a new or subdivision of a current indication.
• Building a rich knowledge of specific Area(s) of Expertise within a phase.
• Utilizing 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
• Chair 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:

• Championing best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group
• Seeking interdependencies and synergies with other trials and programs to enhance excellence in planning and execution across all studies in a phase
• Following 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)
• Embodying a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model.
• Advocating for the COL group and a visible contributor and vehicle to promote interaction

Qualifications

• B.A. or B.Sc. in a scientific discipline; advanced degree preferred.
• Scientifically and clinically astute with very strong project management skills.
• 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.
• Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development.
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
• Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas.
• Balance of scientific and operational/project management and team leadership expertise.
• Ability to build effective relationships across and up and down the organization.
• Ability to establish operational plans and support the CRO in the execution of the plans.
• Effective prior CRO management skills and be able to adapt to the GCO outsourcing model.
• Excellent project management skills, including risk assessment and contingency planning.
• 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.

• Prior investigator site and/or monitoring experience

Additional Information

All your information will be kept confidential according to EEO guidelines.