Principal/Senior Principal Clinical Data Lead

About This Role

The Principal/Senior Principal Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. Manage the flow of all Clinical Data throughout the clinical study lifecycle, from initial Case Report Form (CRF) development to Clinical Study Reporting (CSR). Ensure effective project planning, risk management and provision of high-quality data deliverables. Lead the design and development of eCRFs, ensuring adherence to Biogen standards throughout. Coordinate the development and testing of data management system edit checks and the listings /reports/tools utilized for the data review and discrepancy management activities. Develop Data Management Plan documents utilized to deliver accurate, timely, consistent, and quality clinical data. Acting as the primary and accountable Data Management (DM) representative to the study management team, the Principal/Senior Principal Clinical Data Lead partners with key cross functional team members to develop and implement project plans for assigned studies. Ensures all functional activities are completed by the DM team and/or vendors according to specified quality standards and timelines to support the flawless execution of a clinical trial. May have program level responsibility and where applicable, ensuring consistent delivery of DM activities across studies within a program. Support relevant asset integration activities as required. May support special initiatives both within and outside of the Clinical Data Management department. Develops study level quality/oversight plans and ensures adherence and consistent execution. Performs holistic review of the clinical trial data to assess quality, completeness, and congruency. Identifies areas for process and efficiency improvement and implements solutions on assigned projects. Utilize study metrics and data analytics to monitor study progress and to identify risks and trends within the data. Develop and implement solutions for data management issues and concerns, including proactive prevention strategies. Manages the DM components of the eTMF and creates an audit-ready working environment. As required, represent DM during audit and inspection activities. Lead the develop and execution of CAPAs where appropriate. Support and mentor Clinical Data Managers for assigned trials, fostering strong teamwork. Where a study is outsourced to FSP partner, provide oversight and ensure vendor partner delivers to agreed quality and timelines.

What You'll Do

• Accountable for development of CDM timelines, project management of all end to end data management deliverables in collaboration with cross functional team members and vendors on assigned studies:

• 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.
• Accountable for overall consistency of DM standards across assigned trials/program and quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks)
• Develops risk mitigation or action plans and oversees execution when appropriate.
• Reviews performance metrics and trends for DM deliverables on assigned studies/programs and ensures most optimal execution. Reports/Escalates issues/risks to Portfolio Lead

• Primary contact between DM and clinical study management teams (SMT). Liaises directly with internal customers (Biometrics functions, Clinical, Medical, Safety, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel) .
• Utilizes data review tools to perform holistic review of the clinical study data. Identify trends and issues across the data. Assess risk to data quality. Independently develop and implement solutions at the study level. Share lessons learned across the program/TA/department. Propose the development and/or enhancement of standards.
• Contributes to the development of DM process, data collection and management, reporting, and process improvement and innovation as needed.
• Manages performance and quality issues with vendors (FSP and 3rd party data providers such as labs) and escalates to DM leadership. Develops appropriate risk mitigation, as needed.
• Support study-level/drug program audit and inspection readiness activities as needed
• Supports special projects and initiatives; partners with Statistical Programming, Biostatistics, Vendor Management, and Quality as well as Global Development depending on type of project.

Who You Are

A passionate and experienced Clinical Data Manager, with excellent planning and communication skills. A highly skilled individual with in-depth knowledge of Clinical Data Management systems and strong attention to detail. A functional leader who takes accountability for the delivery of all CDM outputs.

Required Skills

• For Principal Clinical Data Lead: 7+ years relevant work experience with a focus on clinical data management with full accountability across study start-up, conduct, and lock.
• For Senior Principal Clinical Data Lead: 10+ years relevant work experience with a focus on clinical data management with full accountability across study start-up, conduct, and lock.

• Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as eCS elluminate

• Deep understanding of drug development and biopharmaceutical industry required

• Exceptional project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable

• High attention to detail including proven ability to manage multiple, competing priorities

• Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor

• Deep knowledge of clinical data management outsourcing operating model to functional-service providers and full-service/global CROs

• Demonstrated ability to influence without authority

• Excellent written and oral communication skills

Job Level: Management

Additional Information

The base compensation range for this role is: $113,000.00-$175,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:

• 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

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.

Client-provided location(s): Research Triangle Park, NC

Job ID: Biogen-REQ21716

Employment Type: FULL_TIME

Posted: 2025-10-02T23:59:04