Senior Manager, Clinical Operations Lead
- Maidenhead, United Kingdom
- Department: Research & Development
- Region: EU+/Canada
Joining us as Senior Manager, Clinical Operations Lead you will work in alignment with established procedures and SOPs to leverage your phase, indication and operational expertise to independently oversee one or more clinical studies.
This includes partnering with cross-functional representatives to drive the development of operationally feasible and robust protocol designs, ensuring that principles of patient focus, risk management, quality and scientific integrity are applied, exercising appropriate budget responsibility and focused, endpoint-driven cost consideration. You will develop and implement the study-level operational strategy, cascading key operational aspects from the Integrated Development Plan and Global Program Strategy to support delivery of protocol. In addition, you will perform a high-level data driven oversight of Biogen’s CRO partners, securing excellence in execution and alignment with agreed strategy and associated plans.
1) Develops and oversees implementation of the study-level operational strategy for the successful delivery of clinical study(ies):
- Chairs the SMT to drive the development of scientifically robust, operationally feasible, and clear protocol concepts/protocols
- Collaborates strategically with the core SMT (study MD, biostatistics, etc.) and other key program team members to provide direction on phase, disease or therapeutic area to support study design in alignment with the Integrated Development Plan and Global Program Strategy, enabling protocol concept development and driving forward studies through governance approval
- Leverages operational expertise and scientific assessment to evaluate study feasibility and support protocol development
- Aligns team perspectives to develop a cross-functional operational strategy, leveraging expertise, current therapeutic knowledge, and relevant supporting data
- Chairs the Study Management Team (SMT) in partnership with the CRO SMT Lead; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues
- Effectively leads the study via oversight of the CRO, managing performance, quality, and timelines, including defining and delivering against a baseline plan
- Ensures ongoing data review to identify and mitigate patient safety, study design, data integrity or study conduct issues
2. Oversees the delivery of studies by CROs, ensuring quality execution in line with time and budget forecasts:
- Establishes and drives effective and efficient team operations by setting culture of SMT, ensuring thorough team communication, effective goal setting/management and oversight of strategy implementation
- Ensures all operational aspects of the study(ies) conduct support patient safety, endpoint integrity and data validity
- Demonstrates a robust understanding of the study design, rationale, endpoints, and patient population
- Provides oversight via ongoing review of performance and partnership metrics to ensure key milestones and deliverables are achieved
- Collaborates with CFP and procurement functions to ensure FMV is achieved and budget oversight responsibilities are met
- Ensures that all project plans (e.g. Monitoring Plan, Quality Plan, etc.) are in place for effective implementation of studies
- Leads SMT to develop robust Baseline plans, and ensures team is thoroughly prepared for all key governance forums including but not limited to, Baseline, Study Delivery forum, etc.
- Proactively & robustly manages inflection points to ensure any necessary course correction is proactively addressed
- Collaborates with CFP and procurement functions to ensure FMV is achieved and budget oversight responsibilities are met.
- Maintains data accuracy, completeness and quality within study-related systems (e.g. Clarity, Impact, etc.)
3) Strives for effective, consistent, efficient, and compliant processes:
- Champions best practices and seeks opportunities for innovation and efficiency within COSL
- Seeks synergies and commonalities with other studies, programs, and development units to enhance excellence in study planning and execution
- Seeks ways to improve and streamline processes to support the GCO CRO outsourcing models; provides feedback via appropriate channels for opportunities to improve processes or establish best practices
- Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model
- Advocates for the COSL group and actively promotes interaction with other Biogen groups
- Promotes a rich and diverse knowledge base within COSL, contributing SME expertise where applicable
- BA. or BSc. in a scientific discipline; advanced degree preferred.
- Scientifically and clinically astute with very strong project management skills
- A strong background and experience of clinical operations Clinical Trial/Project Management, preferably with both a sponsor company and CRO company, managing outsourced clinical trials within quality, timeline, and budget expectations.
- Prior investigator site and/or monitoring experience is advantageous