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Associate Clinical Data Manager

6-8 years
Not Disclosed
10 Feb. 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Job Title: Associate Clinical Data Manager

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


Company Overview:

Fortrea is a global contract research organization (CRO) offering clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in approximately 100 countries, Fortrea is revolutionizing drug and device development for partners and patients across the globe.


Job Overview:

As an Associate Clinical Data Manager, you will lead data management activities on clinical trials, ensuring high-quality standards for data collection, entry, and validation. You will work directly with sponsors to understand requirements, set up systems, and ensure all data management tasks are executed according to protocol and client expectations. This role requires leadership, coordination with cross-functional teams, and close client engagement to ensure timely database lock and project completion.


Key Responsibilities:

  • Leadership & Data Management:

    • Lead studies involving healthy volunteers and patient populations, across multiple sites.

    • Organize and prioritize workload and deliverables to meet study timelines.

    • Ensure that data management tasks are carried out in line with global SOPs and GCP standards.

    • Lead internal team meetings and ensure alignment with all departments involved in data collection and analysis.

  • Collaboration with Project Manager(s):

    • Collaborate with project managers to build timelines and achieve milestones.

    • Ensure smooth coordination between data management and other teams, including EDC Design, Programming, Statistics, and PK.

  • Client Relations:

    • Develop and maintain client relationships and assess satisfaction.

    • Track scope changes and ensure timely approval from sponsors.

  • Team Development:

    • Provide leadership, mentorship, and coaching to junior data management staff.

    • Support performance evaluations, offering constructive feedback for career development.

  • Risk Management:

    • Identify and address potential risks to meet database lock dates.

    • Perform reconciliation of clinical databases with third-party data as necessary.

  • Process Improvement:

    • Stay updated with new technologies and trends in data management and implement process improvements.


Qualifications:

  • Education:

    • University or college degree (or equivalent work experience).

  • Experience:

    • 6–8 years of data management experience with at least 1 year in sponsor management.

    • Knowledge of clinical trial processes, data management, and biometrics.

    • Experience with Electronic Data Capture (EDC) systems is preferred.

  • Skills:

    • Fluent in English (written and verbal).

    • Strong organizational and time management skills.

    • Excellent communication and interpersonal skills, with the ability to work in a team environment.

  • Preferred:

    • Degree in life sciences, health sciences, information technology, or related fields.

    • Experience in scope management and budget tracking.


Physical Demands/Work Environment:

  • Flexible office and home-based work environment.

  • Willingness to work overtime and weekends as required.


Fortrea’s Culture:

Fortrea fosters an innovative and inclusive culture, guided by their Fortrea FOUR values: Forward Together, Own It, Uphold Integrity, and Respect People. Their mission is to drive meaningful global impact by transforming clinical trials.