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Study Start UP Oversight Lead

About This Role

This role is part of the Clinical Trial Accelerator Unit (CTAU) and is responsible for accelerating Study Start Up activities and ensuring all site activations are made on time in global clinical studies. The individual will harmonize processes and provide start-up expertise to assigned studies and programs, ensuring study teams meet or exceed Final Protocol to First Patient In timelines. The role involves direction and execution, quality compliance, risk management, performance monitoring and cross-functional collaboration.

What You’ll Do

Lead and oversee the execution of site activation for global clinical studies
Develop and maintain critical path and timelines for site activation
Oversee and negotiate timelines for Master Informed Consent Forms (ICFs), including country and site-level ICF creation.
Ensure site activation activities are inspection-ready and compliant with ICH-GCP and Biogen SOPs
Perform or delegate quality checks on submission and site essential documents
Ensure timely and accurate submissions to ethics committees and regulatory authorities
Conduct proactive risk assessments and guide mitigation planning
Analyze metrics and KPIs to monitor performance and drive improvement
Take part in departmental growth initiatives and champion adoption of SSU process improvement tools and templates
Managing relationships with some of our key start up vendors which could include language services providers, translation vendors and printing vendors

Who You Are

You are a subject matter expert with deep expertise in clinical research and study start-up. You thrive in fast-paced environments and excel at managing timelines, mitigating risks, and driving process improvements.

Required Skills

B.A. or B.S. in a scientific discipline; advanced degree preferred
10+ years in Clinical Research with 5+ years in global start-up
Previous experience in a CRO preferred.
Scientifically and clinically astute with very strong project management skills and skilled in planning, tracking milestones, and risk mitigation
Ability to lead and influence in a matrix environment - takes ownership of timelines and deliverables
Proactive mindset with ability to identify bottlenecks and propose solutions
Good organizational, time management, communication, and interpersonal skills
A commitment to maintaining high standards of quality and compliance in all project-related activities
Comfortable using CTMS, eTMF, Veeva, and Microsoft Project
Deep understanding of ICH-GCP, global and local regulatory requirements
Strong technical skills, familiarity with translation management systems
Occasional travel required

Preferred Skills

Experience with IRB/EC submissions

Job Level: Management

Additional Information

The base compensation range for this role is: $134,000.00-$179,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being ; including, but not limited to:

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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

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.

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