Senior 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. Act as subject‑matter expert (SME) for DM activities in relationship meetings with Sponsors.

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. The Senior Clinical Data Manager will work with the leadership team to provide guidance, mentoring and training to DM to ensure best working practices are maintained.

• Lead studies including, but not limited to, healthy volunteer and patient populations, multi‑site, complex protocol design with strong client management requirements.
• Be accountable for all DM deliverables, provide instruction to DM study team(s) and review their output to ensure the highest quality, while adjusting resource allocations as necessary.
• Ensure that all allocated projects are carried out in strict accordance with relevant protocols, global harmonized SOPs and the specified standards of GCPs.
• Work with the Project Manager(s) or FSP Lead (or designee) and DM team, maintaining awareness of other Biometrics functional group deliverables to support risk and mitigation strategies.
• Coordinate the receipt and inventory of all data‑related information from clinical sites and vendors to meet timelines for deliverables.
• Ensure appropriate documentation and procedures are performed upon project completion.
• Develop and maintain client relationships and review client satisfaction surveys.
• Implement action plans and drive process improvements and team training.
• Track scope changes and work with the Project Manager or FSP Lead to secure Sponsor approval and process changes.
• Provide leadership, mentorship, and coaching in DM processes, department technical capabilities, and associated turnaround durations to the internal study team.
• Support DM supervisors and managers in the performance evaluation of other team members, offering constructive feedback.
• Stay current with industry–wide technology and feasibility for process improvement at Fortrea.
• Perform reconciliation of the clinical database against safety data, laboratory data, or other third‑party data as appropriate.
• Utilize local laboratory systems and batch data load facilities where appropriate.
• Represent DM and Biometrics in new business opportunities.
• Attend and action client or internal audits, resolving all issues within an appropriate timeframe.
• Address client comments with the study team.
• Work with management to develop and implement strategy by providing technical input and rolling out training/mentorship to DM staff.
• Actively promote Biometrics services to sponsors whenever possible.
• Perform all other duties as needed or assigned.

• University or college degree, or equivalent experience.
• At least 8 years of combined early or late‑stage DM experience with minimum 2 years of direct sponsor management.
• At least 2 years of technical mentoring experience.
• Proven experience in handling customer negotiations and managing Scope of Work and budgets.
• Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications.
• Proven ability to lead by example on project strategies and achieve department goals, objectives, and initiatives.
• Working knowledge of the regulatory obligations of the CRO industry with pharmaceutical/biotechnological companies.
• Strong time‑management skills and ability to adhere to project productivity metrics and timelines.
• Ability to work in a team environment and collaborate with peers.
• Ability to mentor junior members and provide SME guidance on DM practices.
• Experience representing DM in bid defense meetings, providing innovative solutions to meet client needs.
• Good organizational, communication, and interpersonal skills.
• Constructive…