RA Capital

About This Role

The Senior Manager, CTL, leverages their phase, indication and operational expertise to independently manage and ensure delivery of one or more clinical studies, including:

• 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.

• Developing and implementing the study-level operational plans, cascading key operational aspects from the Integrated Asset Plan (IAP) and Program Operational Plan (POP) to support delivery of protocol.

• Responsible for day-to-day study management, applying competency and experience-based knowledge to ensure the successful delivery of these supportive studies.

• Manages study execution activities, ensuring GCP compliance, tracking milestones and resolving operational risks.

• As a core member of the Study Management Team, leverages available data to help SMTs make informed decisions, securing excellence in execution and alignment with agreed strategy and associated plans.

• Supports the development of comprehensive clinical trial budgets that accurately reflect the costs of all trial activities, including patient care, research procedures, and administrative expenses.

What You’ll Do:

Support the development and executes study-level operations 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.

· As required, 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 Asset Plan (IAP) and Program Operational Plan (POP), 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 support the development of cross-functional operational plans, leveraging expertise, current therapeutic knowledge, and relevant supporting data.

· Supports the day-to-day study operations by building a strong team and fostering a collaborative environment, including clear communications, proactive risk identification and mitigation, and ensuring compliance with the study protocol, GCP and regulatory guidelines.

· Participate in ongoing data review to identify and mitigate patient safety, study design, data integrity or study conduct issues.

· Responsible for developing study budgets that hold up to appropriate scrutiny and align with study endpoint needs.

Responsible for study delivery, ensuring successful execution in line with time and budget forecasts

· 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.

· Performs ongoing review of study performance for outsourced studies, review partnership metrics to ensure key milestones and deliverables are achieved.

· Responsible for the development of all project related plans (e.g. Project Management Plan, Monitoring Plan, Study Risk Management Plan, etc.) for effective implementation of studies.

· Ensure 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, ensuring required information 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 Procurement to ensure FMV transparency, regularly monitoring the budget to identify potential overspending and addressing specific cost drivers.

· Maintains data accuracy, completeness and quality within study-related systems (e.g. Planisware, Veeva CTMS, Beacon, etc.).

· For outsourced studies they lead, 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.

Strives for effective, consistent, efficient, and compliant processes

· Champions best practices and seek opportunities for innovation and efficiency

· 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 department clinical trial outsourcing models; provides feedback via appropriate channels for opportunities to improve processes or establish best practices.

· Advocates for the department and actively promotes interaction with other Biogen groups.

· Promotes a rich and diverse knowledge base, contributing SME expertise where applicable.

Required Skills

· B.A. or B. Sc. in a scientific discipline

· 6 + years in clinical operations management, overseeing outsourced clinical trials per quality, timeline, and budget expectations, preferably with a sponsor company and a CRO

· Related scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skills

· Working knowledge of clinical development related to one or more trial phases (I, II, III, or IV), as well as cross-functional drug development

· Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development

· Ability to develop and execute operational plans in support of clinical trial delivery

· Effective CRO management skills and ability to adapt to fit for purpose clinical trial outsourcing strategies and models

· Working knowledge of the financial aspects of clinical trials including budgeting, financial management, reporting, and analysis

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive

Job Level: Management

Additional Information

The base compensation range for this role is: $141,000.00-$188,000.00