Senior Clinical Data Lead (Hybrid) - Data Excellence

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

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.