Principal Clinical Data Lead - Hybrid (US)

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

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs including,

Vacation + holidays + sick time

401(k) with company match

Employee stock purchase plan

Tuition reimbursement up to $10,000

Job summary

Biogen is seeking a Principal Clinical Data Lead to drive end-to-end data management for clinical trials, ensuring high-quality deliverables and risk management. You will serve as the accountable DM representative on study teams, coordinating DM activities across phases and with CROs and vendors.

The role emphasizes leadership, mentoring of CDMs, and collaboration with Biometrics, Clinical, Medical, and Regulatory functions, with potential program-level responsibilities and process improvement

Qualifications

• 5-7 years of clinical data management experience with accountability across study start-up, conduct, and database lock.
• Experience with data review tools and data management systems.
• Strong knowledge of drug development and biopharma industry.

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

Leadership

Communication

Vendor management

Cross-functional collaboration

Quality focus

Influence without authority

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 drive end-to-end data management for clinical trials, ensuring high-quality deliverables and risk management. You will serve as the accountable DM representative on study teams, coordinating DM activities across phases and with CROs and vendors.

The role emphasizes leadership, mentoring of CDMs, and collaboration with Biometrics, Clinical, Medical, and Regulatory functions, with potential program-level responsibilities and process improvement