Principal, Clinical Data Lead

Biogen, Inc.; Cambridge (MA); Hybrid; USD 122,000 - 163,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insur.

Fitness & Wellness programs

Paid vacation & holidays

Sick time & Parental Leave

401(k) with company match

Tuition reimbursement

Job summary

Biogen, Inc. is seeking a Principal Clinical Data Lead to manage end-to-end data management for clinical trials, ensuring data quality and timely delivery. Lead cross-functional teams and coordinate with Biometrics, Clinical, Medical, Safety, Regulatory, CROs, and FSP partners.

The role emphasizes expertise with EDC systems (Medidata Rave) and data review tools, with a focus on process improvement and inspection readiness within a dynamic biotech environment.

Qualifications

• Bachelor's degree in a scientific or quantitative discipline preferred.
• 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 with the ability to lead cross-functional teams; project management certification preferred.
• 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.

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 DM standards and quality across assigned trials.
• Develop and oversee risk mitigation and action plans.
• Monitor study metrics, identify trends, and elevate 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.

Skills

Clinical data management

Project management

Cross-functional collaboration

Data quality assurance

Risk management

Vendor management

Communication

Education

Bachelor's degree in a scientific or quantitative discipline

Tools

Medidata Rave

eCS Elluminate

Job description

Preference will be given to candidates who can work in a hybrid arrangement, with weekly presence onsite at our offices in Cambridge, MA or in Durham, NC. However, remote work may be available for highly qualified candidates residing within the United States.

About this role

The Principal Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. Manage the flow of clinical data throughout the study lifecycle, from initial eCRF development through clinical study reporting. This role serves as the accountable Data Management representative on study teams, ensuring high-quality data deliverables, effective planning, risk management, vendor oversight, inspection readiness, and successful study execution. The position may support program-level responsibilities, special initiatives, quality oversight, process improvement, and mentoring of Clinical Data Managers.

What you'll do

• 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 DM standards and quality across assigned trials.
• Develop and oversee risk mitigation and action plans.
• Monitor study metrics, identify trends, and elevate 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.

Who you are

A passionate and experienced clinical data leader with exceptional planning, communication, and leadership skills. You bring deep expertise in clinical data management systems, maintain a strong focus on quality and detail, and take accountability for the successful delivery of all CDM outputs.

Required skills

• Bachelor's degree in a scientific or quantitative discipline preferred.
• 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 with the ability to lead cross-functional teams; project management certification preferred.
• 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.

Preferred skills

• Project Management certification.

Additional Information

Job Level: Management

Base salary varies depending on location.

The base compensation range for this role is: $122,000.00-$163,250.00. 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 Biogen.

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.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.