Senior Clinical Data Lead — Hybrid (Cambridge/Durham)

NCBioImpact; Durham (NC); Hybrid; USD 122,000 - 163,000; Full time

Benefits offered by this job

Medical, Dental, Vision, Life ins.

Stock purchase plan

Tuition reimbursement

Paid vacation & holidays

Parental leave

Job summary

Biogen is seeking a Principal Clinical Data Lead to provide leadership in Clinical Data Management for assigned trials. You will manage data flow from eCRF development to study reporting and serve as the accountable DM representative on study teams.

You will mentor CDMs, oversee risk management, vendor oversight, and ensure inspection readiness while driving process improvements and quality deliverables across programs.

Qualifications

• 5-7 years of clinical data management experience with lifecycle accountability.
• Experience across study start-up, conduct, and database lock.
• Deep understanding of drug development and biopharmaceuticals.
• Strong cross-functional collaboration and leadership abilities.

Responsibilities

• Lead end-to-end clinical data management across studies and programs.
• Serve as single point of contact for data management deliverables.
• Ensure consistent DM standards and quality across trials.
• Develop and oversee risk mitigation and action plans.
• Monitor study metrics, identify trends, and elevate risks.
• Collaborate with Biometrics, Clinical, Medical, Safety, Regulatory, CROs, and FSP partners.
• Perform holistic review of study data using data review and analytics tools.
• Drive process improvement and operational excellence initiatives.
• Manage vendor performance and quality issues; support inspections.

Skills

Clinical data management

EDC (Medidata Rave)

Data review tools

Project management

Stakeholder management

Communication skills

Quality assurance

Leadership

Regulatory knowledge

Education

Bachelor's degree in a scientific or quantitative discipline

Tools

Medidata Rave

eCS Elluminate

Job description

Biogen is seeking a Principal Clinical Data Lead to provide leadership in Clinical Data Management for assigned trials. You will manage data flow from eCRF development to study reporting and serve as the accountable DM representative on study teams.

You will mentor CDMs, oversee risk management, vendor oversight, and ensure inspection readiness while driving process improvements and quality deliverables across programs.