Senior Clinical Data Manager

8+ years

Not Disclosed

Bangalore

10 Feb. 13, 2025

Job Description

Job Type: Full Time Education: 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

Senior Clinical Data Manager

Location: Bangalore
Category: Data Management & Data Science
Job ID: 25508

Description:
Fortrea, a leading global contract research organization (CRO), provides pharmaceutical, biotechnology, and medical device customers with clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in ~100 countries, Fortrea is dedicated to transforming drug and device development.

Job Overview:

Lead data management (DM) on studies, ensuring quality, timelines, and budget compliance.
Develop project documentation, system setup, data entry, and validation processes.
Act as a subject matter expert (SME) in client meetings and ensure optimal sponsor-specific processes.
Mentor and train junior DM staff to uphold best practices.

Summary of Responsibilities:

Lead studies with complex protocol designs, multi-site involvement, and tight timelines.
Oversee all DM deliverables and ensure adherence to global SOPs and GCP standards.
Coordinate with project managers and study teams to meet contracted milestones.
Provide leadership in data-focused internal meetings and risk mitigation strategies.
Maintain awareness of biometrics group deliverables to manage resources and risks.
Track scope changes and ensure sponsor approval and process adherence.
Support DM supervisors in team performance evaluations and mentorship.
Stay updated with industry trends and DM technologies for process improvements.
Ensure compliance with DMP and scope of work while maintaining documentation.
Represent DM in client meetings and audits, ensuring resolution of issues.
Promote Biometrics services to sponsors and contribute to strategic direction.

Qualifications (Minimum Required):

University/college degree or equivalent experience.
Fluency in English (reading, writing, speaking).

Experience (Minimum Required):

8+ years of early or late-stage DM experience, with at least 2 years of sponsor management and 2 years of mentoring experience.
Strong knowledge of clinical trials, DM, clinical operations, and biometrics.
Proven leadership skills in project strategies and team management.
Experience handling client negotiations, scope of work, and budgets.
Strong time management and ability to meet productivity metrics.
Prior experience representing DM in bid defense meetings.

Preferred Qualifications:

Degree in life sciences, health sciences, or information technology.
Experience with Fortrea's organizational structure and SOPs.
4+ years of Electronic Data Capture experience.

Physical Demands/Work Environment:

Office or remote-based role with potential risks of repetitive strain injury and eye strain.
Occasional travel (up to 10%) for training, meetings, or cross-site support.

Fortrea is committed to diversity, equity, and inclusion. As an Equal Opportunity Employer, we do not tolerate discrimination based on legally protected characteristics.

For more information about Fortrea, visit www.fortrea.com.

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