Associate Clinical Data Manager

Job Overview: Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff.

Assume responsibility for all DM activities (from study start-up to database lock) according to client quality expectations, within project timelines and budgets. Work directly with Sponsors to understand their direct requirements and lead implementation of those requirements.

Regularly review client specific process to ensure they remain optimal for Sponsor and Fortrea . Summary of Responsibilities: Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, client management required or reduced timelines.

Ability to organize and effectively prioritize workload and deliverables.

Be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly.

Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.

Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings.

Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress.

Maintain awareness of other Bi