Sr. Clinical Data Manager

About the Role

The Senior Clinical Data Manager provides leadership on data management for clinical studies, overseeing project documentation, system setup, data entry, and validation procedures. This role is responsible for all data management activities from study start-up to database lock, ensuring client quality expectations, project timelines, and budgets are met. The position acts as a subject matter expert (SME) in data management during sponsor meetings and works directly with sponsors to implement their requirements.

Responsibilities

• Lead studies involving healthy volunteer and patient populations, multi-site designs, complex protocols, and tight timelines, while managing client relationships.
• Serve as Study Manager, accountable for all data management deliverables, timelines, and team output, ensuring high quality and adjusting resource allocations as needed.
• Ensure projects adhere to relevant protocols, global harmonized SOPs, and Good Clinical Practice (GCP) standards.
• Collaborate with Project Managers or FSP Leads to build and meet contracted milestones, communicating with cross-disciplinary teams and attending study initiation meetings.
• Provide leadership to the data management project team, lead internal meetings, and coordinate with EDC Design, SAS Programming, Statistics, and PK teams to plan and align deliverables toward database lock.
• Proactively identify risks and mitigations, communicate data-driven discussions, and keep Project Managers or FSP Leads informed of progress.
• Maintain awareness of Biometrics functional group deliverables to support risk strategies and consult with management as needed.
• Keep Project Managers, Biometrics management, and sponsor services informed of budget status, scope changes, and timeline impacts.
• Coordinate receipt and inventory of clinical data from sites and vendors to meet deliverable timelines.
• Ensure all project documentation and procedures are completed upon project closure.
• Develop and maintain client relationships, review satisfaction surveys, and implement action plans for process improvements and team training.
• Track scope changes, secure sponsor approval, and process changes with Project Managers or FSP Leads.
• Provide leadership, mentorship, and coaching on clinical trial processes, technical capabilities, and turnaround times to internal teams.
• Support performance evaluations, provide constructive feedback, and aid in career development and competency achievement for team members.
• Stay updated on new data management technologies and processes, assessing feasibility for process improvement.
• Ensure service and quality meet agreed specifications per the Data Management Plan (DMP) and scope of work.
• Contribute to writing, reviewing, and updating SOPs and associated documents.
• Maintain accurate records of all work undertaken.
• Perform database reconciliation against safety, laboratory, or third-party data, utilizing local laboratory systems and batch data load facilities.
• Represent data management and, where necessary, Biometrics in new business opportunities.
• Attend and address client or internal audits, resolving issues promptly and addressing client feedback with the study team.
• Collaborate with management to develop and implement strategic direction, providing technical input and rolling out training or mentorship to staff.
• Actively promote Biometrics services to sponsors.
• Perform other related duties as assigned by management.

Requirements

• University or college degree; equivalent experience and education may substitute for a bachelor’s degree.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Proficiency in English (speaking, writing, reading) is required.
• Minimum of 8 years of combined early or late-stage data management experience, with at least 2 years of direct sponsor management and 2 years of technical mentoring experience.
• Proven experience in customer negotiations, managing Scope of Work, and budgets.
• Thorough knowledge of the clinical trial process, data management, clinical operations, biometrics, and supporting system applications.
• Ability to lead project strategies, achieve department goals, and encourage solution-oriented teamwork.
• Working knowledge of CRO industry relationships and regulatory obligations with pharmaceutical or biotechnology companies.
• Strong time management skills and ability to adhere to project timelines and productivity metrics.
• Ability to work collaboratively in a team environment and mentor junior staff, providing SME guidance on data management practices.
• Experience representing data management in bid defense meetings and offering innovative solutions to meet client needs.
• Strong organizational, communication, and interpersonal skills.
• Constructive problem-solving approach while managing deadlines, incomplete information, or unexpected events.

Preferred Qualifications

• Degree in life sciences, health sciences, information technology, or related fields.
• In-depth knowledge of Fortrea’s organizational structure and Standard Operating Procedures (SOPs).
• Four or more years of Electronic Data Capture (EDC) experience.

Work Environment

• Role is office or remote-based, with risks of repetitive strain injury (keyboard operation) and eye strain (VDU screen use).
• Potential travel for cross-site support, training, or meetings up to 10% of the time, with up to 50% of travel requiring overnight stays.

Pay

$85,000–$120,000 per year.

Benefits

• Comprehensive benefits for regular, full-time or part-time employees working 20+ hours per week, including:
  • Medical, dental, and vision coverage.
  • Life, short-term disability (STD), and long-term disability (LTD) insurance.
  • 401(K) retirement plan.
  • Paid time off (PTO) or Flexible time off (FTO).
  • Company bonus where applicable.