Remote
Senior Manager, Data Management
About this role
Overview Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal.
With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves. Join us, as we reshape the future. Summary of job description: The Senior Manager, Data Management (DM) is responsible for clinical data management activities across all phases of clinical trials and program assignments.
This role serves as the internal expert in all areas of clinical data management processes and technology. The Senior Manager, Data Management will lead the development of department documents and procedures and oversee and/or mentor other data management staff. This position can be based either in our Woburn office or be a remote role - Our Woburn location welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.
- Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require. Key responsibilities: · Review/Management of DM activities in vendor proposals, budgets and scopes of work. · Reviews and provide input into protocols, SAP, IB, CSR and other clinical study documents during development. · Responsible for DM vendor oversight at the study level.
· Function as internal DM Study lead, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports; Work to ensure on-time achievement of major data management deliverables and milestones in coordination with other functions. · Review and manage key documents such as data management plan, guidelines for CRF completion, data review, SAE reconciliation, and data audits.