Senior Manager, Data Management
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. We imagine a world where cancer is a curable disease.
At Replimune, we live by our values:
United: We Collaborate for a Common Goal.Audacious: We Are Bold and Innovative.
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, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients, caregivers and themselves.
Join us, as we reshape the future.
Job Summary:
The Senior Manager, Data Management (DM) is responsible for clinical data management activities for all phases of clinical trials and programs. This role participates in or oversees data management staff in cross functional teams, with both internal and external collaborators or contract research organizations.Also serves as the internal expert in all areas of clinical data management processes and technology. The Senior Manager, Data Management will also 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- 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.
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 program 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. Provide DM-level review and input on all study medical coding
- 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 and Protocol Deviation specifications document, 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
- Work with SAS and/or clinical systems programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews). Provide input on standard tools and reports.
- 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 Biometrics and cross-function team to assess and implement electronic systems for improving data management processes data aggregation tools, and emerging EDC technology.
Qualifications:
Education:
- Bachelor’s degree in scientific/technical discipline
Required Experience:
- 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
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response.The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.
The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
We are an Equal Opportunity Employer.