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Associate Clinical Data Manager (Eds)

6-8 years
Not Disclosed
10 Sept. 25, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.