Manager – Clinical Data Management (CDM) | Bangalore, India
Experience Required: 8–10 years (including 2–4 years in supervisory roles)
Education: B.Sc. in Life Sciences/Pharmacy or equivalent; relevant certifications considered
Job Category: Data Management & Data Science | Employment Type: Full-Time
Company Overview
Fortrea is a leading global provider of clinical data management and life sciences solutions, supporting pharmaceutical, biotechnology, and medical device organizations in delivering high-quality, compliant clinical trials. Our teams drive operational excellence and innovation across multiple therapeutic areas, ensuring timely, accurate, and reliable clinical data for regulatory submissions worldwide.
Role Overview
The Manager, CDM is responsible for leading and supervising CDM teams to achieve service delivery excellence, ensure compliance with global standards, and optimize resource utilization. This role combines people management, operational oversight, and process improvement responsibilities within clinical data management and associated support activities, including EDC account management, data entry, eTMF documentation, and decommissioning.
Key Responsibilities
Team Leadership & Development:
Supervise, mentor, and evaluate a team of 10–15 staff members across one location, fostering professional growth and competency development.
Conduct performance reviews, training programs, and technical coaching to enhance team effectiveness.
Support recruitment and onboarding of new team members based on skills, availability, and project requirements.
Operational Management:
Oversee EDC user account activations, modifications, and deactivations.
Manage data entry, eTMF documentation, and decommissioning activities to ensure accurate and timely clinical data delivery.
Maintain productivity, quality metrics, and adherence to internal and client-defined SLAs.
Support resource allocation, revenue and operating margin targets, and time/cost estimates for projects.
Process Improvement & Compliance:
Identify local and regional data management challenges and implement process improvement strategies.
Support the development and harmonization of SOPs and quality processes for CDM operations.
Ensure adherence to ICH/GCP guidelines and international regulatory requirements.
Participate in quality management activities, including internal audits and QA reviews.
Client & Stakeholder Engagement:
Support client satisfaction by ensuring high-quality data delivery on-time and within budget.
Address staff performance or quality issues identified through client feedback or internal metrics.
Collaborate with business development teams for project planning and cost estimation.
Candidate Profile
Qualifications & Education:
B.Sc. in Life Sciences, Pharmacy, or related field. Relevant certifications (e.g., Nursing, Medical, Laboratory Technology) considered.
Equivalent experience in CDM, data entry, eTMF management, or User Account Management may be considered.
Experience:
8–10 years in clinical data management or related domains, including 2–4 years in a supervisory role.
Experience managing teams in a global or regional clinical trial setting.
Knowledge across multiple therapeutic areas preferred.
Technical & Regulatory Skills:
Comprehensive understanding of clinical trial processes, data handling, and eTMF management.
Familiarity with global CDM tools, resource management systems, and productivity metrics.
Strong knowledge of ICH/GCP guidelines and regulatory obligations for CROs and pharmaceutical companies.
Soft Skills:
Excellent communication, presentation, and stakeholder management abilities.
Proven ability to mentor, motivate, and develop high-performing teams.
Strong analytical, problem-solving, and decision-making skills.
Work Environment:
Office-based role with associated risks of repetitive strain and eye strain from computer use.
Why Join Fortrea?
Lead high-performing teams in a global clinical data management organization.
Gain exposure to multi-therapeutic clinical trials and global regulatory standards.
Contribute to operational excellence and innovation in CDM processes.
Access professional growth opportunities, training, and development programs.
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