Sr. Manager - Clinical Trial Lead

Biogen; Milwaukee (WI); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental, and Vision insurance

Short- and Long-Term Disability insurance

401(k) plan with matching contributions

Job summary

A leading biotechnology company based in Milwaukee is seeking a Senior Manager to independently manage clinical studies with a focus on operational excellence and compliance. Candidates should hold a Bachelor's degree in a scientific discipline and have over 6 years of experience in clinical operations management. The ideal candidate will possess strong project management skills and expertise in Good Clinical Practices. Comprehensive benefits are included, such as health insurance, paid vacation, and a 401(k) plan with matching contributions.

Qualifications

• 6+ years in clinical operations management overseeing outsourced clinical trials.
• Extensive scientific and clinical expertise.
• Strong working knowledge of Good Clinical Practices (GCP) and regulatory requirements.

Responsibilities

• Independent management of clinical studies ensuring delivery and compliance.
• Develop operational plans and work with cross-functional teams.
• Chair the Study Management Team and manage budgets.

Skills

Clinical operations management

Project management

Risk assessment

Communication skills

Education

Bachelor’s degree in a scientific discipline

Tools

Planisware

Veeva CTMS

Beacon

Job description

About This Role

Senior Manager, CTL responsible for independently managing and ensuring delivery of one or more clinical studies, leveraging phase, indication, and operational expertise.

Responsibilities

• Partner with cross‑functional representatives to develop operationally feasible protocols, applying patient focus, risk management, quality, and scientific integrity principles, and exercise budget responsibility.
• Develop and implement study‑level operational plans, cascading key components from the Integrated Asset Plan (IAP) and Program Operational Plan (POP).
• Oversee day‑to‑day study management, ensuring GCP compliance, milestone tracking, and resolution of operational risks.
• Chair the Study Management Team (SMT), leveraging data to inform decisions, secure excellence in execution, and align with strategy and plans.
• Support development of comprehensive clinical‑trial budgets that reflect all trial activities.
• Collaborate strategically with core SMT members and program team to provide direction on phase, disease, or therapeutic area, enabling protocol development and governance approval.
• Leverage operational expertise and scientific assessment to evaluate study feasibility and support protocol development.
• Ensure all operational aspects of the study conduct support patient safety, endpoint integrity, and data validity.
• Perform ongoing review of study performance for outsourced studies, reviewing partnership metrics to achieve milestones.
• Develop and maintain project‑related plans (Project Management Plan, Monitoring Plan, Study Risk Management Plan, etc.) and ensure implementation.
• Manage inflection points proactively to ensure necessary course corrections.
• Collaborate with Procurement to ensure fair‑market‑value transparency, monitor the budget, and address cost drivers.
• Maintain data accuracy, completeness, and quality within study‑related systems (Planisware, Veeva CTMS, Beacon, etc.).
• For outsourced studies, lead and chair the SMT in partnership with the CRO SMT Lead, ensuring appropriate risk mitigation plans.

Qualifications

• Bachelor’s degree (BA or BS) in a scientific discipline.
• 6+ years in clinical operations management, overseeing outsourced clinical trials, with experience at a sponsor company and a CRO.
• Extensive scientific and clinical expertise, and exceptional project‑management, risk‑assessment, contingency‑planning, and communication skills.
• Strong working knowledge of clinical development across one or more trial phases (I, II, III, or IV) and cross‑functional drug development.
• Expertise in Good Clinical Practices (GCP), International Council for Harmonisation (ICH) guidelines, and regulatory requirements.
• Ability to develop and execute operational plans supporting clinical trial delivery.
• Effective CRO management skills and ability to adapt to fit‑for‑purpose clinical trial outsourcing strategies and models.
• Understanding of the financial aspects of clinical trials, including budgeting, financial management, reporting, and analysis.

Benefits

In addition to compensation, Biogen offers a highly competitive range of benefits designed to support employees and their families’ physical, financial, emotional, and social well‑being:

• Medical, Dental, Vision, & Life insurance
• Fitness & Wellness programs including a fitness reimbursement
• Short‑ and Long‑Term Disability insurance
• Paid vacation: minimum of 15 days plus 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 up to $10,000 per calendar year
• Employee Resource Group participation

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States.