Senior Manager – Clinical Trial Lead

Role Overview

• 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.
• 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.

Requirements

• 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.

Tech Stack

• Google Cloud Platform

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short
• and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation