Senior Project Lead - Clinical Data Management
Cambridge, MA, United States
Biogen
Biogen is a leading global biotechnology company that pioneers science and drives innovations for complex and devastating diseases. Biogen is advancing a pipeline of potential therapies across neurology, neuropsychiatry, specialized immunology...Company Description
At Biogen, we offer a workplace that is unique, connected, resilient and impactful. Our purpose to find cures for rare diseases is a unique focus within our industry. We are connected as a team by this shared purpose, the pride we have in our work, and the inspiration we obtain from the lives we’re changing. We are resilient as we overcome obstacles, following the science to deliver for our patients. Most of all, our work allows us to have an impact. An impact on our patients’ lives and on changing the course of medicine.
Job Description
About this role
The Senior Principal Clinical Data Lead (Biogen specific job title) provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They will manage the flow of all Clinical Data throughout the clinical study lifecycle, from initial Case Report Form (CRF) development to Clinical Study Reporting (CSR).
What you’ll do
- Single point of contact for the execution of data management deliverables on assigned trials/programs. Interprets and applies data strategy, ensures use of global/program standards, coordinates and oversees outsourced personnel, and monitors and reports on overall study progress.
- Primary contact between Data Management and Clinical Study Management team
- Contribute to the development and maintenance of Data Management processes, data standards, reporting, program process improvement and innovation
- Supervise Clinical Data Managers/Leads
- Manage and resolve complex data management issues
- May serve as project lead across therapeutic area indications, strategic projects and initiatives
Who You Are
You are recognized as a subject matter expert for both operational and technical delivery in clinical trial data management, proficient in leading project teams to success, and are passionate about the clinical trial arena.
Qualifications
Required Skills
- Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
- 10+ years relevant work experience with a focus on clinical data management with full accountability across study start up, conduct, and lock.
- Expert in drug development and biopharmaceutical industry required
*Biogen is currently hiring for positions at multiple levels within the Data Management team and will consider your skillset for the appropriate level.*
Additional Information
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive
All your information will be kept confidential according to EEO guidelines.
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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.
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: Biology Computer Science Data management Data strategy Economics Mathematics Statistics
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