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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 strategic leadership and execution, quality compliance, risk management, performance monitoring and cross-functional collaboration.
What You’ll Do- Lead the strategy and execution of site activation activities for global clinical studies across diverse regions (e.g., North America, Europe, APAC, LATAM).
- 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
- Manage cross-functional collaboration and resource allocation to support study start-up.
- Lead departmental growth initiatives and champion adoption of SSU process improvement tools and templates
You are a strategic leader with deep expertise in global clinical research and multi-regional study start-up operations, adept at navigating complex regulatory landscapes and driving cross-functional collaboration across diverse geographies. 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 clinical trial start-up
- Previous experience in a CRO essential, preferably in a senior start-up role leading cross-functional teams and managing global SSU deliverables
- Scientifically and clinically astute with very strong project management skills and skilled in planning, tracking milestones, and risk mitigation
- Deep understanding of ICH-GCP, global and local regulatory requirements
- Experience with IRB/EC submissions
- 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
- Comfortable using CTMS, eTMF, Veeva, and Microsoft Project
- Occasional travel required
- Experience in Veeva and Microsoft Project
Additional Information
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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