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
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
Job Level: Management
Additional Information
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.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to:
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
Why Biogen?
Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offEquity / stock optionsPerformance bonusParental leave
Additional Information
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).
Biogen · Cambridge, MA