Job Description
About the Role
This role is a member of the Clinical Trial Accelerator Unit (CTAU) taking broad responsibility for accelerating Study Start Up activities, harmonizing processes and providing start-up expertise to studies and programs to which they are assigned, to ensure study teams meet and exceed the Final Protocol to First Patient In timelines and ensure all sites in the study are activated on time. This role is predominantly an oversight role and works in close collaboration with the Clinical Trial Lead (CTL) who has overall accountability for the study. The Study Start Up Project Manager (SSU PM) is responsible for ensuring that Study Start Up and site activation deliverables are achieved in a timely and efficient manner, compliant with Biogen SOPs and procedural documents, applicable local regulations and international guidelines such as ICH and GCP. Tasks vary from study to study but include building out a MS Project plan for all activities and holding the team accountable for task driven progress, maintaining the Quantitative Science and Development Operations (QSDO) study dashboard, as well as closely monitoring individual site activations. Other activities the SSU PM may get involved in include: Feasibility, Site Selection, Site contracting and budgets, Vendor set-up, Informed Consent management, and overall site engagement. The SSU PM may support special projects, develop templates, materials and processes or perform other assigned tasks as needed. The SSU PM would be expected to be proficient in MS Project.
Qualifications
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Who You Are
EDUCATION AND REQUIRED SKILLS:
- B.A. or B.S. in a scientific discipline; advanced degree preferred.
- Scientifically and clinically astute with very strong project management skills.
- Good knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
- Proficiency in MS Project
- Advance use of MS Excel
- Previous use of Veeva CTMS and Study Start Up module would be ideal.
- At least 5 years of clinical research experience of which at least 3 years of Study Start Up management experience with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations.
- Prior CRO or investigator site and/or monitoring experience is a plus.
- Good organizational and time management skills
- Good communication and interpersonal skills
- Good negotiation skills
- Ability to work in a matrix environment
Additional Information
The base compensation range for this role is $124,000 to $200,000 base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
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.