Sr Manager, Case Mgmt, Clinical Trial Safety

About This Role

The Sr Manager Case Management, Clinical Trial Safety will be responsible for managing the in-house case processing of clinical trial safety reports (and some post-market reports) in Biogen’s safety database. This role includes hands-on case processing and QC of ICSRs, workflow management, quality management, responsibility for the SMP and team line management. The Sr Manager will ensure consistent, on time and high-quality output of clinical trial ICSRs, working with cross-functional stakeholders.

What You’ll Do

• Overall case management activities for clinical trial ICSRs
• Author and maintain the SMP
• Perform data entry and in-line QC as well as retrospective QCLiaise 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

Who You Are

• You are a seasoned case processor with a passion for quality and compliance.
• You have successfully managed case processing teams with high quality ICSRs and on time regulatory submissions.
• You are agile and decisive and will take initiative to use data to drive proposals for process improvements or quality initiatives.

Required Skills

• 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

Pay

The base compensation range for this role is: $141,000.00-$188,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

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
• Up to 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