Associate Clinical Data Manager

3+ years

Not Disclosed

Bangalore

10 Feb. 13, 2025

Job Description

Job Type: Full Time Education: B.E./BCS/B.Tech/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Location: Bangalore
Category: Data Management & Data Science
Job ID: 2447287

Description:
Fortrea, a global contract research organization (CRO) with a commitment to scientific excellence, provides pharmaceutical, biotechnology, and medical device companies with a wide range of clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in approximately 100 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

Job Overview:
The Associate Clinical Data Manager (ACDM) provides leadership in Data Management (DM) on studies, overseeing project documentation, system setup, data entry, and validation procedures. The role requires assuming responsibility for all DM activities from study start-up to database lock, ensuring client quality expectations, project timelines, and budget adherence. The ACDM works directly with sponsors to understand their requirements and implements optimal data processes.

Responsibilities:

Lead studies involving healthy volunteers and patient populations, multi-site trials, and client management.
Organize and prioritize workload to meet deliverables within tight timelines.
Ensure all DM deliverables align with established timelines, providing guidance to study teams.
Adhere to protocols, global SOPs, and Good Clinical Practice (GCP) standards.
Work with Project Managers to develop timelines and coordinate interdepartmental activities.
Lead data-focused internal project meetings and collaborate with EDC Design, SAS Programming, Statistics, and PK teams.
Identify potential risks and mitigations, ensuring database lock dates are met.
Maintain awareness of Biometrics functional group deliverables and support risk mitigation strategies.
Keep Project Managers and Biometrics management informed about project progress and any scope changes.
Develop and maintain client relationships, addressing satisfaction surveys.
Track scope changes and obtain sponsor approvals as needed.
Provide leadership, mentorship, and coaching in DM-related clinical trial processes.
Support DM managers in evaluating team performance and providing constructive feedback.
Stay updated with new DM technologies and industry advancements for process improvement.
Perform reconciliation of clinical databases against safety, laboratory, and third-party data.
Represent DM in business opportunities and client interactions.
Attend and resolve client/internal audits within appropriate timeframes.
Promote Biometrics services to sponsors and participate in additional assigned duties.

Qualifications (Minimum Required):

University/college degree. Equivalent work experience may be considered.
Fluent in English (written and verbal).

Experience (Minimum Required):

6 to 8 years of Data Management experience, with at least 1 year of direct sponsor management.
Experience handling customer concerns, managing scope of work, and budgets preferred.
Knowledge of clinical trials, data management, biometrics, and system applications.
Strong time management skills with the ability to meet productivity metrics.
Team-oriented mindset with good collaboration, organizational, and interpersonal skills.
Understanding of medical terminology.

Preferred Qualifications:

Degree in life sciences, health sciences, information technology, or related fields.
Scientific background preferred.
Knowledge of Fortrea’s structure, SOPs, and industry standards.
3+ years of Electronic Data Capture (EDC) experience.

Physical Demands/Work Environment:

Office and home-based work environment.
May require overtime and weekend work.
Willingness to work flexible shifts per business needs.

About Fortrea:
Fortrea seeks innovative problem-solvers passionate about overcoming clinical trial barriers. The company is committed to accelerating development processes to deliver life-changing therapies. Fortrea fosters a collaborative environment that supports personal and professional growth, enabling employees to make a meaningful global impact.

Equal Opportunity Employer Statement:
Fortrea is an Equal Opportunity Employer (EOE/AA) committed to diversity and inclusion. The company does not tolerate discrimination or harassment based on race, religion, gender, age, disability, or other protected characteristics. Employment decisions are based on business needs and individual qualifications.

For details on Fortrea’s data collection practices, refer to the Privacy Statement.

If you require accommodation during the hiring process, contact taaccommodationsrequest@fortrea.com (for accommodation requests only).

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Associate Clinical Data Manager

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