Sr Manager, Case Mgmt, Clinical Trial Safety
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Job Location:
Cambridge, MA - USA
Monthly Salary:
$ 141000 - 188000
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 Biogens 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 Youll 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.
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
Additional Information
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 $10000 per calendar year
- Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Required Experience:
Manager
Key Skills
- Project Portfolio Management
- Motivational Interviewing
- HIPAA
- Computer Skills
- Intake Experience
- Lean Six Sigma
- Conflict Management
- Case Management
- Team Management
- Program Development
- Social Work
- Addiction Counseling
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
