Lead Clinical Data Manager – Woburn, MA
The Lead Clinical Data Manager (LDM) works under supervision and is responsible for all clinical data management activities for studies assigned. This role participates in cross functional team communications and meetings with both internal and external collaborators and oversees the data management activities at contract research organizations (CRO). The Lead Clinical Data Manager will also participate in the development of department documents and procedures and mentor more junior data management staff.
- Functions as internal Data Management Study lead, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports. Works to ensure on-time achievement of major data management deliverables and milestones in coordination with other functions
- Reviews and provides input into protocols and other clinical study documents during development
- Reviews and manages 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 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
- Provide input on Replimune specifications for internal study team data review plan and guidelines and Protocol Deviation specifications document
- Participates in study team data review; Perform data review for quality issues and general data trends; generate queries as necessary
- Defines/oversees 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 Data Management function at study 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
- Participate in development and implementation of departmental initiatives. Develop or improve data management SOPs and guidelines
Educational and Experience/Skill requirements:
- Bachelor’s degree in scientific/technical discipline is required
- 5+ years of relevant work experience with a focus on data management
- Knowledge of clinical data management outsourcing with full-service global CROs and niche service providers
- Experience 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
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
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