Sr Manager, Case Mgmt, Clinical Trial Safety
About The Position
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. The Sr Manager will report to the Director of Clinical Trial Safety Operations within the Global Case Management function of Safety & Regulatory Operations, Medical Writing and Benefit Risk Management (SABR).
Requirements
- 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
Nice To Haves
- Seasoned case processor with a passion for quality and compliance
- Successfully managed case processing teams with high quality ICSRs and on time regulatory submissions
- Agile and decisive
- Will take initiative to use data to drive proposals for process improvements or quality initiatives
Responsibilities
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
