Hybrid Clinical Data Manager — CRO Oversight & Analysis

Biogen; Cambridge (MA); Hybrid; USD 117,000 - 157,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insur.

401(k) with company match

Tuition reimbursement up to $10,000

Employee stock purchase plan

Paid vacation and holidays

Job summary

Biogen is seeking a Data Manager in the Implantable Device Unit to lead clinical data management for studies, coordinating with internal teams and external CROs. You will develop data management plans, ensure protocol alignment, and generate data listings and summaries to support monitoring and decision-making.

As a hybrid role based at our Cambridge, MA headquarters, you will drive data quality, oversee CRO activities, and support regulatory submissions with robust data analyses and reporting.

Qualifications

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

Responsibilities

• Oversee CRO data management activities by reviewing deliverables, timelines, and resolving issues to align with study requirements.
• Generate clinical data reports, listings, and summaries using programming tools for study monitoring and decision-making.
• Fulfill internal data requests by preparing ad hoc analyses and targeted outputs for stakeholders across functions.
• Monitor data quality and database readiness by identifying issues and coordinating revisions with CROs.
• 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.
• Support protocol deviation assessment and documentation quality.
• Assist in regulatory submissions and safety reviews with data outputs.

Skills

SAS

Python

Advanced Excel

Power Query

Education

Bachelor's degree in clinical data management or related field

Job description

Biogen is seeking a Data Manager in the Implantable Device Unit to lead clinical data management for studies, coordinating with internal teams and external CROs. You will develop data management plans, ensure protocol alignment, and generate data listings and summaries to support monitoring and decision-making.

As a hybrid role based at our Cambridge, MA headquarters, you will drive data quality, oversee CRO activities, and support regulatory submissions with robust data analyses and reporting.