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Sr Clinical Data Associate

3+ years
Not Disclosed
10 Nov. 6, 2025
Job Description
Job Type: Full Time Hybrid Remote 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

Position: Senior Clinical Data Associate (Sr CDA)
Location: Mumbai, Maharashtra, India
Job ID: R-01331305
Employment Type: Full-time
Category: Clinical Research
Remote Option: Fully Remote
Company: Trialmed (Part of PPD, Thermo Fisher Scientific Inc.)
Work Schedule: Standard (Monday to Friday, 1:00 PM – 10:00 PM IST)
Environmental Conditions: Adherence to GMP and Safety Standards


Summary

The Sr Clinical Data Associate at Trialmed will support data management projects in early-phase clinical research. This role emphasizes accurate data handling, adherence to protocols, and collaboration with global teams to advance scientific research and clinical studies.


Key Responsibilities

  • Support study setup activities: database design, data entry screen testing, Data Validation Manual (DVM) creation.

  • Identify, resolve, and update data discrepancies in the database.

  • Generate, track, and resolve data clarifications and queries; may implement CRF designs.

  • Review data listings for accuracy and consistency; analyze and resolve validation reports.

  • Act as a subject matter expert for study-specific processes.

  • Train and provide work direction to junior staff.

  • Contribute to global process improvements in data management.

  • Produce project-specific status reports for CDM management and clients.

  • Perform data management activities, including SAE and third-party vendor reconciliations.

  • Execute advanced data cleaning tasks according to GCP and SOPs/WPDs.

  • Work independently on complex assignments, recommending solutions and new procedures.

  • Communicate effectively with external stakeholders and internal teams, requiring tact and negotiation skills.


Education and Experience

  • Bachelor’s degree or equivalent formal academic qualification.

  • Minimum 3+ years of experience in data management or related field.

  • Combination of education, training, and relevant experience may also be considered.


Knowledge, Skills, and Abilities

  • Highly organized, detail-oriented, with proficiency in Microsoft Office.

  • Strong written and verbal communication skills in English.

  • Analytical and problem-solving skills with moderate supervision.

  • Quick learner, adaptable to new environments and Generative AI tools.

  • Effective interaction with global teams; strong interpersonal and customer-focused skills.

  • Experience with DM EDC databases (Medidata Rave, Veeva Vault) and good documentation practices (eTMF).

  • Ability to maintain confidentiality with clinical and proprietary data.

  • Knowledge of medical/clinical trial terminology, project protocols, and DVMs.

  • Flexible, adaptable, and capable of working independently or in a team.


Work Conditions

  • Standard hours: 1:00 PM – 10:00 PM IST

  • Flexible work options: Office, remote, or hybrid


Mission

Join Trialmed to contribute your expertise in clinical data management and support the development of new therapies, making the world healthier, cleaner, and safer.

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