Replimune Senior Manager, Data Management at Replimune responsible for clinical data management across all phases of clinical trials. Lead data management activities, oversee vendors, and develop department documents and procedures.
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.
Following CDISC conventions, oversee or perform eCRF design and annotation, database design specifications; Develop or oversee CRO generation of data edit check specifications; Participate in user acceptance testing (UAT) of the clinical database, including edit check testing.
Create Replimune specifications for internal study team data review plan and guidelines, with input from study team.
Lead internal study team in data review; Perform data review for quality issues and general data trends; generate queries as necessary. Provide guidance to others on program-level internal data review standards.
Define/oversee data transfer specifications for external data sources (labs, ECGs, PK) and transfer of data; reconcile or oversee CRO lab reconciliation with clinical database to escalate important compliance and quality risks cross-functionally.
Work with programming resources and vendors to produce custom data reports and data visualization tools.
Represent Replimune DM function at program level, and with internal colleagues. Function as study DM liaison with cross-functional team members and external vendors to ensure completion of all timelines and study-related tasks.
Give Data Management presentations and/or training at investigator or other meetings.
