Sr. Clinical Data Manager
The Clinical Data Manager will coordinate clinical data management activities for phase I-IV clinical trials by supervising outside vendors and contractors, as well as performing data quality checks to ensure the integrity of the clinical data. The incumbent ensures that all data management procedures are executed with accuracy and timeliness.
- Oversee clinical data management activities across multiple studies, prepare DM minutes, agendas, data process flow maps and internal timelines
- Assist in the design of the eCRFs and ensure that they conform to Principia’s standards
- Supervise vendors that have been contracted to handle Principia’s data (e.g., EDC and IRT vendors, CROs, Labs, etc.) and ensure the data are complete, accurate and delivered within the timelines agreed to
- Perform thorough reviews of critical CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans.
- Perform User Acceptance Testing (UAT) on development of EDC and IRT systems
- Ensure data transfer specifications are in place and review data transfers for consistency with Principia data standards and SDTM specifications
- Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells
- Perform supplemental data reviews according to the data quality checks outlined in the edit check specifications document, data plans and as requested by the clinical team.
- Participate in reviews of TFL output prior to final database locks
- Ensure that all data management documentation have been collected and uploaded to the relevant sections of the working files on the server and the study TMF
- Report query trends and data/query metrics and oversee suggest any changes, additional training as appropriate
- Prioritize projects and coordinate data management activities in support of corporate goals and objectives
- Contribute to departmental compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices
- Address the business needs of CDM functional customers
- Serve as the data management representative on projects and communicate the status of data timelines, changes, issues and risks to the project team and leadership.
- Proficiency in Microsoft Office (Word, Excel, Outlook), electronic TMF, and electronic clinical technologies
- Working knowledge of SAS databases and SAS programming
- Multi-task in a fast paced environment
- Work without close supervision both independently and as part of a team
- Proactively foresee and solve problems and commit to a high level of service
- Build strong cooperative relationships with coworkers
- Work well with people from a variety of different backgrounds and cultures
- Write complex documentation without direct supervision
- Possess a high degree of attention to detail
- Propose solutions and schedule all problem solving activities under indirect supervision in clear project plan with defined goals, decisions, and endpoints
- Previous employment at a pharmaceutical or biotech company or CRO
- BA or BS degree with a minimum of 7 years relevant experience in a life science industry; or equivalent combination of education and experience.
- 4 years relevant working knowledge of CDISC and SDTM standards
- Superior written and spoken communication skills in English
- Ability to clearly communicate complex issues, observations and resolutions to management
- Exercise judgment within broadly defined procedures and policies in selecting methods, techniques, and evaluation criteria for obtaining solutions
- Work on complex problems where the analysis of situations or data requires in-depth evaluation
- May determine methods and procedures on new assignments