Biogen · 1 week ago
Sr. Principal, Clinical Data Lead
Cambridge, MA
Full-time
Onsite
Senior Level, Lead/Staff
$131K/yr - $185K/yr
7+ years expBiogen is a global biotechnology company focused on transforming the lives of patients with severe immune-mediated diseases. The Senior Principal, Clinical Data Lead will provide leadership and expertise in Clinical Data Management for clinical trials, ensuring operational excellence and accountability throughout the study lifecycle.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Primary point of contact for the execution of Data Management deliverables on assigned trials and programs. Interprets and applies data strategy, ensures use of global program standards, coordinates and oversees Data Management study team members, and monitors and reports overall study progress
Accountable for all Data Management activities throughout the study lifecycle. This includes oversight of all Data Management tasks and performing tasks such as document creation, data cleaning, and query management
Accountable for Data Management standards across assigned trials and programs. Ensures high utilization of CRF and edit check standards library components
Develops and executes plans for risk identification and mitigation
Assesses operational metrics to optimize process efficiency
Assesses study metrics and effectively communicates data topics across internal and external teams, escalating relevant issues for timely resolution
Oversees issue investigation and solution proposals using experience, judgement, and precedent
Contributes to the development of Data Management process, including new process creation, process improvement, and innovation as applicable
Manages quality and efficiency performance with vendors, including Data Management FSP team members and external vendor data providers. Develops and implements strategies and plans for improvement when needed
Leads and participates in cross-functional collaborations, including study level activities and special projects or initiatives
Qualification
Required
Bachelor's degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc
7+ years relevant work experience with a focus on Clinical Data Management. 4+ years as a Lead Data Manager with full accountability across study start-up, conduct, and lock
Robust technical experience with Electronic Data Capture platforms (Medidata Rave preferred) and use of data review tools (elluminate preferred)
Strong project management skills to effectively lead and collaborate with various business functions
Excellent written and oral communication skills in English is required
Ability to effectively communicate with a variety of cross-functional teams in a variety of scenarios
High attention to detail, including proven ability to manage multiple competing priorities successfully
Deep understanding of drug development and the biopharmaceutical industry
Benefits
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
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