Job Summary:
Partners with COLs and/or Study Management Team members to support the development of operationally feasible and clear protocol concepts and final protocols. Leverages phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level strategy for assigned studies and programs.
Oversees one or more clinical studies by securing excellence in execution through guidance from primary COL and working in partnership with the CRO. On some studies when appropriate, the Clinical Operations Manager may work independently to oversee the execution of the study.
May partner with CSL Leadership to oversee CSL specific initiatives or areas of control and process improvement.
Principle Accountabilities:
1. Oversees clinical aspects of their assigned study or as directed by primary COL including: Proactively identifies and works with CRO to resolve clinical project issues; Oversees clinical vendors including the partner CRO, either working independently or with the primary COL for all elements of oversight, including, but not limited to reporting, regulatory requirements, study budgets, Study Operational Strategy (SOS), quality of endpoint data, good clinical practice and patient safety.
2. Support operational excellence and delivery for one or more clinical studies by:
• Managing the study operational strategy (SOS) with guidance from the lead COL or COS
• Providing input to operational strategy (including ancillary vendors) aligned with the program strategy and working closely with the Clinical Country Lead (CCL) to set the country strategy, incorporating country input through the primary COL and study CCL
• Overseeing the tactical execution of the operational strategy by the partner CRO; effectively providing oversight of the CRO, including close monitoring of CRO work on established baseline plans, highlighting areas in need of focus to assure issues are raised and resolved so baselines can be achieved
• Utilizing operational expertise and scientific assessment to evaluate study feasibility: assess end point measurement options, and ensure the successful execution of study(ies).
• Driving performance, quality, timelines and relationships through the CRO partnership model
• Ensuring clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs, and that the studies are conducted with a focus to being inspection-ready at any given time point
• Chairing/Co-chairing the Study Management Team in partnership with the CRO study Lead; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues.
• Overseeing delivery of the study to budget
3. Strives for effective, consistent, efficient and compliant processes by:
• Participating in best practice development in Phase planning and seeking opportunities for innovation and efficiency with the Clinical Study Leadership group
• 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.
• Being an advocate for the CSL group and a visible contributor and vehicle to promote interaction.
• Providing input on behalf of CSL into process and business initiatives with the opportunity to also oversee and manage CSL specific areas of focus, reporting into CSL Leadership
Job Criteria:
• Regular interactions with Clinical Operations Sciences (COS), COLs, CRO Project Leads and Clinical Leads, study Medical Director, members of the cross-functional SMT, and CSL Leadership.
• Ability to handle a high volume of highly complex tasks within a given timeline. Ability tomanage various phases of clinical trials. Makes study level operational decisions with minimal oversight from the Primary COL, where applicable.
• Able to understand, evaluate and provide input into process or business evolvement discussions in alignment with CSL direction. Able to manage utilization of more junior resources in delivery of studies, work deliverables or work allocation e.g. CTC.
Knowledge & Skills:
• Working Knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
• Strong clinical study management skills and ability to work independently.
• Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership, prioritization and team building skills.
• 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.
• 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 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.