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Jobs / Clinical Data Manager in United States of America
1 month ago
Fortrea·1 month ago
1 month ago

Manager, Clinical Data Management

San Jose, United States of AmericaMid · 5-10 years

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About this role

Fortrea is expanding its Clinical Data Management team and we're looking for a Manager, Clinical Data Management (CDM) to join our organization. This is an exciting opportunity to lead and develop high-performing data management teams while supporting the successful delivery of global clinical trials.
 

Job Overview:

Provide leadership, oversight, and strategic direction for Clinical Data Management teams. Responsible for resource planning, staff development, quality oversight, operational delivery, and process improvement initiatives to ensure teams consistently meet client expectations, project goals, and business objectives.

Partner with cross-functional stakeholders to support global clinical development programs, drive operational excellence, and foster a culture of accountability, collaboration, and continuous improvement. Ensure team members are appropriately trained, supported, and positioned to deliver high-quality outcomes in accordance with regulatory requirements, SOPs, and company standards.


Summary of Responsibilities:

  • Manage team resources and workforce planning activities to meet business objectives and service commitments.
  • Lead, mentor, coach, and develop Clinical Data Management staff, supporting career growth and achievement of competency standards.
  • Monitor and manage team productivity, quality, utilization, and performance metrics, implementing action plans as needed.
  • Support recruitment, interviewing, onboarding, and workforce planning activities to maintain appropriate staffing levels.
  • Provide oversight of operational Clinical Data Management activities and ensure timely, high-quality delivery of assigned responsibilities.
  • Partner with project teams and leadership to support successful study execution and achievement of client expectations.
  • Identify operational challenges and implement solutions to improve efficiency, quality, compliance, and team performance.
  • Support quality management initiatives and quality control activities to ensure accurate, timely, and consistent delivery of clinical data.
  • Contribute to the development, implementation, and maintenance of departmental processes, procedures, and best practices.
  • Drive continuous improvement initiatives and promote operational excellence across teams.
  • Manage resource allocation and capacity planning to support changing business and project needs.
  • Support business development activities through resource planning, feasibility assessments, and operational input as needed.
  • Ensure employee performance reviews, training plans, development activities, and compliance requirements are completed in accordance with company guidelines.
  • Foster a positive, collaborative, and inclusive team environment.
  • All other duties as needed or assigned.

Minimum Qualifications:

  • University degree in Life Sciences, Health Sciences, Pharmacy, Nursing, Medical Technology, Laboratory Sciences, or a related discipline.
  • Equivalent experience in clinical research, clinical data management, pharmaceutical development, or related fields may be considered in lieu of formal education requirements.
  • Fluent in English, both written and verbal.
  • Strong understanding of clinical research and drug development processes.
  • Knowledge of ICH-GCP guidelines and applicable regulatory requirements.
  • Understanding of resource management, workforce planning, and operational management principles.

Experience (Minimum Required):

  • 8–10 years of experience in clinical research, clinical data management, or related operational functions.
  • 2–4 years of direct people management experience.
  • Demonstrated experience leading and developing teams in a clinical research, biotechnology, pharmaceutical, or CRO environment.
  • Experience with resource planning, utilization management, capacity forecasting, and productivity metrics.
  • Strong understanding of clinical trial processes and data management operations.
  • Proven ability to coach, mentor, and develop employees while driving engagement and performance.
  • Excellent communication, presentation, stakeholder management, and problem-solving skills.
  • Experience leading process improvement initiatives and driving operational excellence.
  • Ability to effectively manage multiple priorities and adapt to changing business needs.

Preferred Qualifications Include:

  • Prior people leadership experience within a CRO, pharmaceutical, or biotechnology organization.
  • Experience supporting global clinical development programs.
  • Experience managing geographically diverse teams.
  • Experience supporting client-facing teams and delivering against operational objectives and service commitments.

Work Environment:

  • Primarily remote work environment.
  • Occasional attendance at the office may be required for team meetings, training sessions, business activities, or collaboration events.
  • May require flexibility to support global teams and stakeholders across multiple time zones.

Learn more about our EEO & Accommodations request here.

H1B sponsor likely
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