Study Start Up Project Manager
Study Start Up Project Manager
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Salary Not Disclosed
1 Vacancy
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 startup 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 setup 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 :
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 ICHGCP 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 $124000 to $200000 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 Biogens LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical dental life long and shortterm disability insurances vacation endofyear 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 midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 EVerify Employer in the United States.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- Project Management Methodology
- Project / Program Management
- Construction Estimating
- Construction Experience
- PMBOK
- Visio
- Construction Management
- Project Management
- Project Management Software
- Microsoft Project
- Project Management Lifecycle
- Contracts
