Associate Clinical Data Manager (EDS)
Location: Bangalore
Category: Data Management & Data Science
Job ID: 253042
Job Overview
The Associate Clinical Data Manager will provide leadership in Data Management (DM) across studies, ensuring high-quality project documentation, system set-up, data entry, and data validation. This role includes oversight of junior staff, direct interaction with Sponsors, and implementation of client-specific requirements. The position is accountable for all DM activities from study start-up to database lock, ensuring compliance with client expectations, timelines, and budgets.
Key Responsibilities
1. Study Leadership & Management
Lead studies involving healthy volunteers and patient populations across multi-site projects.
Organize and prioritize workload and deliverables effectively.
Be accountable for DM deliverables and ensure high-quality output from study teams.
Ensure adherence to protocols, global SOPs, and GCP standards.
Collaborate with Project Managers to create and manage timelines, including study initiation meetings.
2. Project Coordination & Communication
Provide leadership to DM project teams and conduct internal meetings focused on data.
Coordinate with EDC Design, SAS Programming, Statistics, and PK teams to align deliverables.
Identify risks and mitigation strategies; communicate data-driven insights to achieve database lock.
Keep Project Managers and Biometrics management informed about project progress, budget, and scope changes.
3. Client Relationship & Quality Assurance
Develop and maintain client relationships; review client satisfaction surveys.
Track scope changes and ensure Sponsor approval is received.
Attend internal or client audits and resolve issues within appropriate timelines.
Actively promote Biometrics services to Sponsors.
4. Mentorship & Team Development
Provide guidance, mentorship, and coaching to internal DM teams.
Support DM managers in performance evaluation and career development of team members.
Share knowledge of new DM technologies and process improvements.
5. Data Reconciliation & Reporting
Reconcile clinical databases with safety, laboratory, or third-party data.
Utilize laboratory systems and batch data load facilities where appropriate.
Maintain accurate records of all work undertaken.
Qualifications
Minimum Required:
University/college degree (relevant experience may substitute for formal education).
Fluent in English (written and verbal).
6–8 years of DM experience, with at least 1 year of direct sponsor management.
Experience in handling customer concerns, scope of work, and budget management.
Knowledge of clinical trial processes, DM systems, biometrics, and clinical operations.
Strong time management, organizational, communication, and interpersonal skills.
Knowledge of medical terminology.
Preferred Qualifications:
Degree in life sciences, health sciences, IT, or related field.
Scientific background or knowledge of science.
Thorough knowledge of Fortrea and its SOPs.
3+ years of Electronic Data Capture (EDC) experience.
Physical Demands & Work Environment
Office and home-based work environment.
May require overtime or weekend work.
Flexible shift willingness as per business requirements.
EEO & Accommodations
Learn more about Fortrea’s Equal Employment Opportunity and accommodations here.
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