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. 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 ICSRsAuthor and maintain the SMPPerform data entry and in-line QC as well as retrospective QCLiaise with ICSR Medical Evaluation team to solicit quality feedback and implement improvementsOversee case workflowReview and resolution of clinical/safety database reconciliationOversee clinical trial queries to sites/Investigators, escalating as requiredManage late case investigations for late regulatory reportingManage translations of source documents via vendorCollaborate with TMF Operations and Clinical Safety OperationsManagement of unblind accounts for CT ICSR SUSAR reportingWho You AreYou 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 healthcare7+ years of relevant PV experience, including clinical trial experienceDirect line management and/or case processing team managementKnowledge of global and local safety regulationsExcellent written and verbal communication skillsExcellent project management skillsMust be effective and collaborative in a fast-paced and matrixed environmentEffective managerial skillsStrong decision making skillsJob Level: ManagementAdditional InformationThe base compensation range for this role is: $141,000.00-$188,000.00Base 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 insurancesFitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insuranceA 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 yearPaid Maternity and Parental Leave benefit 401(k) program participation with company matched contributionsEmployee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participationWhy 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 on to learn more about Biogen.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.SummaryLocation: Cambridge, MAType: Full time