Clinical Data Team Lead (CDTL) – Clinical Data Management
Company: [Insert Company Name]
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Data Management
Experience Required: 4 – 6 years in Clinical Data Management
Job Overview
We are looking for a Clinical Data Team Lead (CDTL) to manage end-to-end clinical data management activities for one or more studies. The CDTL will lead data management teams, oversee data quality, and ensure all deliverables meet timelines, regulatory standards, and client expectations.
This role will act as a primary liaison to project leadership and clients, manage study metrics, forecast resources, mentor team members, and contribute to bid and project administrative activities.
Key Responsibilities
Data Management Leadership
Lead CDM activities from study setup to database lock, ensuring compliance with protocol, SOPs, GCP, and regulatory guidelines
Direct and mentor CDM team members, providing study-specific guidance and training
Monitor study metrics and produce regular status reports for clients and management
Identify and communicate potential out-of-scope activities and support contract modification processes
Develop and maintain data management documentation and perform independent review of deliverables
Project Coordination & Client Liaison
Serve as the primary point of contact for project leads and clients regarding CDM activities
Assist in business development activities, including bid preparation and bid defense support
Contribute to administrative and financial management of assigned studies, including resource forecasting and budget tracking
Quality & Compliance
Ensure high-quality, inspection-ready datasets for clinical trials
Apply protocol-specific requirements to team workflows and review CDM deliverables for completeness and accuracy
Maintain confidentiality and data integrity across all project activities
Education & Experience
Education:
Bachelor’s degree or equivalent in Life Sciences, Pharmacy, or related field
Experience:
4 – 5.6 years in clinical data management
Demonstrated experience with RAVE / Veeva EDC systems
Skills & Competencies
Strong understanding of clinical trial protocols, SOPs, and GCP guidelines
Excellent written and verbal communication skills in English
Proven leadership and mentoring abilities
Strong analytical, organizational, and problem-solving skills
Ability to manage multiple projects and priorities independently
Attention to detail and commitment to data quality and compliance
Flexibility and adaptability to work in remote and collaborative environments
Career Growth & Global Exposure
Opportunity to progress along the Clinical Data Management (CDM) track (e.g., Senior CDM, CDTL, CDM PM)
Exposure to international clinical trials, CRO collaborations, and global study teams
Hands-on experience with modern CDM systems, AI-enabled workflows, and data quality processes
Build expertise in inspection-ready datasets, data standards, and study metrics
Gujarat :
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