Sr.Clinical Operations Lead

• This role focuses on phase 4 work and requires solid experience with multiple phase 4 studies.

• 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.

• Identifies strategic operational approaches that span program(s) partnering with the D COS to champion the evaluation and implementation as appropriate.

• Positively impacts the performance of other COLs (or the COM group) by, for example, initiating and leading discussions at peer level forums relevant to the COL role and development in line with GCO best practices.

• Viewed and sought out as an operational expert from functions across GCO and across Development Sciences.

• 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. 

• 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.

• Developing operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country Lead 

• Closely working with Director COS to fully leverage the cross study tactical execution to drive consistency and efficiency within a program

• May also be responsible for the driving, of 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. They are a mentor / SME for the COM group and leveraged by other groups within GCO and across Development Sciences for their operational expertise.

• 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

• Initiates, leads and shares best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group

• Identifies interdependencies and synergies with other trials and programs and seeks to proactively put into place process or forum 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

• Is an influential leader and a resource for COLs within the Clinical Operations Management group.

• Initiates and leads discussions at peer level forums relevant to the COL role and development in line with GCO best practices.

• Participates, presents, leads and facilitates topics at COM group meetings. 

• Participates, presents, leads and facilitates key development sciences initiatives (e.g. ASL iHub)

• Directly influences clinical study risk and success. Works closely with key scientific leaders, CRO global lead, Vendor Management, Operation Lead, study or program MDs, Program Directors, Study Management Team members including Regulatory Affairs, Medical Affairs, Commercial, Discovery, and Analytical Development.

• Viewed and sought out as an operational expert from functions across GCO and across Development Sciences.