Sr Manager, Case Mgmt, Clinical Trial Safety
About The Position
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. 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). 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 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 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.
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
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
