Data Manager

Biogen • Cambridge, MA

1d • Hybrid

About The Position

As a Data Manager in the Implantable Device Unit, you will play a crucial role in supporting the planning, oversight, and execution of clinical data management activities for studies. You'll act as the primary internal point of contact for data management operations, coordinating with both internal functions and external partners. Your responsibilities will include contributing to the development and maintenance of study data management plans, ensuring activities align with protocols, timelines, quality expectations, and regulatory requirements. By generating data listings, reports, and summaries using appropriate programming and data analysis tools, you'll aid study monitoring and internal decision-making. Additionally, you'll fulfill ad hoc data requests, resolve data issues, and collaborate with cross-functional stakeholders to support data quality and study results interpretation. This position is vital for providing leadership and hands-on support for effective study data oversight and CRO performance. This is a hybrid role to be based at our Headquarters in Cambridge, MA.

Requirements

• Bachelor’s degree with at least 5 years of experience in clinical data management or related fields.
• Proficiency in generating data outputs using SAS, Python, and advanced Excel tools (Power Query and/or similar tools).
• Experience in oversight of CRO data management activities.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration abilities.

Nice To Haves

• Advanced degree
• Experience with implantable devices and Class III medical device studies.
• Familiarity with regulatory submissions and protocol amendments.

Responsibilities

• Oversee CRO data management activities by reviewing deliverables, timelines, and resolving issues to ensure alignment with study requirements.
• Generate clinical data reports, listings, and summaries using programming tools to support study monitoring and decision-making.
• Fulfill internal data requests by preparing ad hoc analyses and targeted outputs for stakeholders across various functions.
• Monitor data quality and database readiness by identifying issues and coordinating needed revisions.
• Partner with cross-functional stakeholders on data-related deliverables and issue resolution.
• Collaborate on study data strategy, data review priorities, and CRO oversight.
• Coordinate data cleaning priorities and query management with external vendors.
• Partner on protocol deviation assessment and documentation quality.
• Support resolution of quality issues affecting compliance or data integrity.
• Provide data outputs and analyses for regulatory submissions and safety reviews.
• Review study progress and operational issues impacting data quality and interpretation.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager