Senior Manager, Clinical Trial Lead

Biogen

. Lead the operational planning, execution, and delivery of one or more clinical studies .

Posted 10/26/2026full-timeUnited StatesSenior💰 $141,000 - $188,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical operations management, including oversight of outsourced clinical trials, project management, and risk assessment. Proficient in developing operational plans and ensuring compliance with GCP, ICH guidelines, and global regulatory requirements.

Highest-signal resume keywords

Clinical Operations ManagementProject ManagementRisk AssessmentGCP ComplianceCRO Management

ATS Keywords

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Hard Skills

Clinical Trial ManagementOperational PlanningBudget ManagementData IntegrityQuality ManagementRegulatory ComplianceContingency PlanningStudy Feasibility EvaluationCross-Functional CollaborationPerformance Oversight

Soft Skills

Communication SkillsLeadershipProblem-Solving

Tools & Technologies

Clinical Trial Management Systems

Industry Keywords

Phase I-IV StudiesImmunologyRare DiseaseNeurologyICH Guidelines

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead the operational planning, execution, and delivery of one or more clinical studies
Chair the Study Management Team (SMT) and drive cross-functional study execution
Partner with Medical, Biostatistics, Regulatory, and other stakeholders to develop operationally feasible protocols and study strategies
Evaluate study feasibility and develop operational, monitoring, quality, and risk management plans
Manage study timelines, budgets, forecasts, and governance deliverables
Identify, assess, and mitigate operational risks while maintaining patient safety, data integrity, and regulatory compliance
Oversee CROs, vendors, and outsourced partnerships, ensuring performance, milestone achievement, and issue resolution
Monitor study performance and conduct ongoing data reviews to identify and address quality, safety, or execution issues
Maintain accurate, inspection-ready study documentation and data within clinical trial management systems
Champion process improvements, operational excellence, and best practices across studies and development programs
Partner with Clinical Operations, Medical, Biostatistics, Regulatory, Data Management, and external partners to support program and asset strategies

Requirements

What you’ll need

Bachelors degree 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
Scientific and clinical expertise with strong project management, risk assessment, contingency planning, and communication skills
Working knowledge of clinical development across Phase I-IV studies and cross-functional drug development
Demonstrated experience managing CROs, vendors, and outsourced clinical trials, including governance, performance oversight, budgets, quality, and outsourcing strategies
Expertise in GCP, ICH guidelines, and global regulatory requirements for clinical development
Proven ability to develop and execute operational plans that support successful clinical trial delivery
Preferred: Experience in Immunology, Rare Disease, or Neurology

Benefits

Comp & perks

Regular employees are eligible to receive short term and long-term incentives, including cash bonus and equity incentive opportunities
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
Opportunities for learning, growth, and expanding skills