Senior Manager, Case Management, Clinical Trial Safety

Biogen

Sr Manager in Clinical Trial Safety at Biogen overseeing case processing and quality management for clinical trial reports. Collaborating with various departments to ensure high-quality output.

Posted 6/11/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSenior💰 $141,000 - $188,000 per yearWebsite

About the role

Key responsibilities & impact

Overall case management activities for clinical trial ICSRs
Author and maintain the SMP
Perform data entry and in-line QC as well as retrospective QC
Liaise with ICSR Medical Evaluation team to solicit quality feedback and implement improvements
Oversee case workflow
Review and resolution of clinical/safety database reconciliation
Oversee clinical trial queries to sites/Investigators, escalating as required
Manage late case investigations for late regulatory reporting
Manage translations of source documents via vendor
Collaborate with TMF Operations and Clinical Safety Operations
Management of unblind accounts for CT ICSR SUSAR reporting

Requirements

What you’ll need

BS degree in science or healthcare
7+ years of relevant PV experience, including clinical trial experience
Direct line management and/or case processing team management
Knowledge of global and local safety regulations
Excellent written and verbal communication skills
Excellent project management skills
Must be effective and collaborative in a fast-paced and matrixed environment
Effective managerial skills
Strong decision making skills

Benefits

Comp & perks

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

ATS Keywords

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Hard Skills & Tools

case managementdata entryquality controlclinical trial managementdatabase reconciliationregulatory reportingtranslations managementproject managementcase processing

Soft Skills

communication skillscollaborationmanagerial skillsdecision makingorganizational skills

Certifications

BS degree in scienceBS degree in healthcare