Principal, Clinical Data Lead

Biogen•Durham, MA

6d•Hybrid

About The Position

The Principal Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. The role manages clinical data flow throughout the study lifecycle, from initial eCRF development through clinical study reporting, and serves as the accountable Data Management representative on study teams. The position ensures high-quality data deliverables, effective planning, risk management, vendor oversight, inspection readiness, and successful study execution. It may also support program-level responsibilities, special initiatives, quality oversight, process improvement, and mentoring of Clinical Data Managers. The preferred arrangement is hybrid, with weekly onsite presence at the company’s offices in Cambridge, Massachusetts, or Durham, North Carolina. Remote work may be available for highly qualified candidates residing in the United States. The role is part of a global biotechnology company focused on delivering medicines and fostering inclusion and belonging. The base salary range is $122,000 to $163,250, with the offered salary determined by factors including relevant skills and experience, job location, and internal equity. Regular employees may also be eligible for short- and long-term incentives, including cash bonuses and equity opportunities.

Requirements

5–7 years of clinical data management experience with accountability across study start-up, conduct, and database lock.
Robust experience with EDC platforms such as Medidata Rave and data review tools including eCS elluminate.
Deep understanding of drug development and the biopharmaceutical industry.
Strong project management skills and ability to lead cross-functional teams.
Exceptional attention to detail and ability to manage multiple competing priorities.
Experience building and maintaining effective external stakeholder and vendor relationships.
Deep knowledge of data management outsourcing models, including FSP and CRO partnerships.
Demonstrated ability to influence without formal authority.
Excellent written and verbal communication skills.
A bachelor's degree in a scientific or quantitative discipline is preferred.

Nice To Haves

Project management certification.

Responsibilities

Lead end-to-end clinical data management activities across assigned studies and programs.
Serve as the single point of contact for execution of data management deliverables on assigned studies and programs.
Ensure consistent application of Data Management standards and quality across assigned trials.
Develop and oversee risk mitigation and action plans.
Monitor study metrics, identify trends, and escalate risks as appropriate.
Partner with internal and external stakeholders, including Biometrics, Clinical, Medical, Safety, Regulatory, CROs, and FSP partners.
Perform holistic review of study data using data review and analytics tools.
Drive process improvement, innovation, and operational excellence initiatives.
Manage vendor performance and quality issues and support audit and inspection readiness.
Support special projects and cross-functional initiatives.
Mentor Clinical Data Managers.

Benefits

Short- and long-term incentives, including cash bonuses and equity incentive opportunities, for eligible regular employees.
Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
At least 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
80 hours of sick time per calendar year.
Paid maternity and parental leave.
401(k) program with company-matched contributions.
Employee stock purchase plan.
Tuition reimbursement of up to $10,000 per calendar year.
Employee Resource Groups participation.