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-Senior Clinical Data Associate

3+ years
Not Disclosed
10 Nov. 25, 2025
Job Description
Job Type: Full Time Remote 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

Senior Clinical Data Associate – Trialmed (PPD | Thermo Fisher Scientific)

Location: Mumbai, Maharashtra, India
Work Model: Fully Remote
Job Type: Full-Time
Category: Clinical Research


About the Role

Trialmed, the early phase clinical solution for PPD (the clinical research business of Thermo Fisher Scientific), is seeking a Senior Clinical Data Associate (Sr CDA) to support global clinical data management operations. This role is ideal for professionals with strong technical expertise in data management, GCP-aligned practices, and clinical database systems. As a Senior CDA, you will collaborate with global teams, support end-to-end data management processes, and contribute to the delivery of high-quality clinical datasets that support regulatory submissions and clinical development programs.


Key Responsibilities

  • Support study setup activities including database design, testing of electronic data capture (EDC) systems, and preparation of Data Validation Manuals (DVMs).

  • Identify, resolve, and update data discrepancies while ensuring database integrity and protocol compliance.

  • Generate, track, and resolve clinical data queries; support CRF design implementation as required.

  • Review data listings for accuracy and consistency, ensuring adherence to GCP, SOPs, and project-specific requirements.

  • Serve as a subject matter expert for specialized data management activities and study processes.

  • Provide training, guidance, and task direction to junior data management team members.

  • Support global improvement initiatives related to data management workflows, standards, and system efficiency.

  • Prepare and deliver project-specific status reports for internal teams and client stakeholders.

  • Perform data reconciliation activities for Serious Adverse Events (SAEs) and third-party vendor data.

  • Execute advanced data cleaning activities, ensuring readiness for analysis, safety review, and regulatory submission.

  • Independently manage complex tasks requiring sound judgment, initiative, and technical expertise.

  • Coordinate with internal and external stakeholders, requiring strong communication, negotiation, and cross-functional collaboration skills.


Education Requirements

  • Bachelor’s degree or equivalent in life sciences, pharmacy, health sciences, or related discipline.


Experience Required

  • Minimum 3+ years of clinical data management experience, ideally within a CRO or clinical research environment.

  • Hands-on experience with EDC platforms such as Medidata Rave and Veeva Vault is highly preferred.

  • Strong understanding of good documentation practices, eTMF workflows, and clinical trial terminology.


Key Skills and Competencies

  • Strong organizational skills with the ability to manage multiple priorities while adhering to global SOPs and regulatory requirements.

  • Excellent attention to detail, analytical mindset, and numerical proficiency.

  • Strong command of written and verbal English, with the ability to communicate effectively across global teams.

  • Proficiency in Microsoft Office applications and interactive data management tools.

  • Ability to adapt quickly to new technologies, including Generative AI tools used in data review and efficiency workflows.

  • High degree of confidentiality, professionalism, and ethical conduct when handling clinical and proprietary information.

  • Ability to work both independently and collaboratively within cross-functional and multicultural environments.

  • Knowledge of project protocols, clinical data standards, and Data Validation Manuals.


Working Conditions

  • Standard working hours: 1:00 PM to 10:00 PM IST.

  • Work options include remote, office-based, or hybrid, based on employee preference and operational needs.


Why Join Trialmed?

As part of the PPD and Thermo Fisher Scientific clinical research ecosystem, you will contribute to high-impact projects that help make the world healthier, cleaner, and safer. This role offers global exposure, structured career growth, and the opportunity to work with industry-leading clinical data platforms.