Senior Manager, Data Management

Replimune•Woburn, MA

2d•Hybrid

About The Position

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. 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.

Requirements

Bachelor’s degree in scientific/technical discipline
10+ years of relevant work experience with a focus on data management
Deep knowledge of clinical data management outsourcing with full-service global CROs and niche service providers
Expertise in clinical oncology indications, end points, data flow, data integrity, standards and data quality
Strong project management skills and ability to lead and collaborate effectively with cross-functional teams

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.
Lead and/or participate in development and implementation of departmental initiatives. Develop or improve data management SOPs and guidelines.
May have direct reports; serve routinely as resource or mentor for other DM personnel. Partner with appropriate stakeholders for issue resolution.
Works closely with leadership team in Data Management and the cross-functional team to assess and implement electronic systems for improving data management processes data aggregation tools, and emerging EDC technology.