Manager, CDM
Fortrea · Durham, NC · 3 wk ago
OTHR$100k–$130k/yrFull-time
Job ID: 85026. Application deadline: August 8, 2026. Remote role.
About the role
Manage resources based on forecast models to meet or exceed business Service Level Agreements. Oversee user account management, data entry, decommissioning, and eTMF documentation tasks. Support recruitment, quality management, and process improvement initiatives to ensure accurate, timely, and high-quality clinical data delivery.
Responsibilities
- Supervise, mentor, evaluate, and support staff development, career growth, and competency achievement.
- Oversee EDC user account activations, deactivations, modifications, data entry, decommissioning, and eTMF documentation tasks.
- Maintain productivity and quality indicators for global staff; support recruitment of new candidates.
- Identify and implement solutions for local and regional data management issues, including preventive strategies based on metrics and forecasts.
- Assist with quality management activities per Global Data Management Plans and Quality Management (QM) Plans, including in-process quality control to ensure accurate, timely, and consistent clinical data.
- Support locally based project staff in achieving client satisfaction (internal and external) through quality data delivery, on-time and on-budget.
- Assist in developing and executing training programs to ensure staff achieve position competencies.
- Support development of global, harmonized SOPs and quality processes for user account management, data entry, eTMF documentation, and decommissioning.
- Identify and implement process improvement solutions to meet revenue and operating margin targets.
- Create action plans to address staff quality and performance issues identified via client feedback or satisfaction surveys.
- Manage staff utilization and billability, plan resource allocation, and support recruitment based on skills, competencies, and availability.
- Provide support to Business Development for time and cost estimates.
- Ensure staff reviews (performance, training, development) are completed per Fortrea guidelines.
- Perform all other duties as needed or assigned.
Requirements
- B.Sc. degree in Life Science, Pharmacy, or equivalent/related discipline, or certification in a related allied health profession (e.g., Nursing, Medical or Laboratory Technology) from an accredited institution (preferred).
- In lieu of the above, approximately 18 months of relevant experience in pharmaceutical, laboratory, or data analysis fields, including one year of clinical data management experience, plus five years of experience in user account management, data entry, or eTMF documentation.
- Broad knowledge of the drug development process.
- Understanding of global clinical development budgets and productivity targets.
- Knowledge of resource management systems/processes and time/cost estimate development.
- Thorough knowledge of ICH/GCP Guidelines, including international requirements for clinical development programs, especially related to data handling and processing.
Qualifications
- Eight to ten (8-10) years of relevant work experience, with two to four (2-4) years of supervisory experience in user account management, data entry, eTMF documentation, and knowledge of multiple therapeutic areas.
- Demonstrated experience managing a team of 10 to 15 employees within one regional location (Asia Pac, Europe, North America, etc.).
- Excellent oral and written communication skills, with strong presentation abilities.
- In-depth knowledge of the clinical trial process and staff productivity metrics.
- Demonstrated skill in mentoring and developing staff on technical and core competencies.
- Working knowledge of the CRO industry’s regulatory obligations with pharmaceutical/biotechnology companies.
- Ability to lead local teams on business strategies and achievement of department goals, objectives, and initiatives, encouraging solution-seeking among team members.
Physical Demands
- Office-based role with risks of repetitive strain injury (keyboard operation) and eye strain (VDU screen operation).
Pay
$100,000–$130,000 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).