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Sr Clinical Data Associate

3+ years
Not Disclosed
10 Dec. 12, 2025
Job Description
Job Type: Full Time 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

Senior Clinical Data Associate (Sr CDA)

Location: Mumbai, Maharashtra, India
Job ID: R-01331305
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote


About the Role

Trialmed, the early-phase clinical research arm for PPD® (part of Thermo Fisher Scientific), is seeking a Senior Clinical Data Associate to lead high-quality data management activities within global clinical studies. This role is integral to advancing clinical research programs that address critical global health challenges.

As part of a leading global CRO, you will support end-to-end data management processes, collaborate with international teams, and ensure the highest standards of data accuracy, compliance, and operational excellence.


Work Schedule & Compliance

  • Schedule: Standard (Monday to Friday)

  • Regulatory Requirement: Adherence to all Good Manufacturing Practices (GMP) and safety standards


Key Responsibilities

  • Support study setup activities, including electronic database design, testing of data entry screens, and Data Validation Manual (DVM) development.

  • Identify, review, and resolve data discrepancies while maintaining accuracy within the clinical data management systems.

  • Generate and manage data clarifications and queries; contribute to CRF design in approved design platforms.

  • Conduct detailed reviews of data listings to ensure consistency and compliance with validation rules.

  • Serve as a subject matter expert for study-specific processes and provide support to junior team members.

  • Contribute to global process improvements and standardization of data management activities.

  • Prepare regular project status updates for internal stakeholders and clients.

  • Perform critical data management tasks including SAE reconciliation, third-party vendor data checks, and detailed data cleaning.

  • Apply advanced judgment on complex issues, recommending improved solutions or new procedures when needed.

  • Engage with external partners or key internal stakeholders, requiring strong planning, communication, and negotiation skills.

  • Ensure all tasks align with GCP guidelines, SOPs/WPDs, and regulatory expectations.


Required Education and Experience

  • Bachelor’s degree or equivalent academic qualification.

  • Minimum 3 years of experience in clinical data management or a related discipline.

  • Equivalent combinations of education, training, or experience may be considered.


Knowledge, Skills, and Abilities

  • Strong understanding of regulatory compliance, global SOPs, and client deliverables.

  • High attention to detail, strong numerical accuracy, and excellent command of MS Office tools.

  • Excellent written and verbal communication skills in English.

  • Strong analytical, organizational, and problem-solving skills.

  • Ability to work with moderate supervision and to proactively manage assigned tasks.

  • Fast learner with the ability to adapt to new technologies, including Generative AI tools.

  • Effective collaboration with global, multicultural teams and strong customer focus.

  • Experience with EDC systems such as Medidata Rave and Veeva Vault; familiarity with good documentation practices (e.g., eTMF).

  • Strong understanding of clinical trial terminology, study protocols, and DVM requirements.

  • Ability to maintain strict confidentiality of clinical and proprietary data.

  • Flexible, self-motivated, and capable of working independently or within team environments.


Working Conditions

  • Work Hours: 1:00 PM – 10:00 PM IST

  • Work Options: Office-based, remote, or hybrid based on preference


Join Our Mission

Be part of a global clinical research organization committed to making the world healthier, cleaner, and safer. As a Senior Clinical Data Associate, you will contribute directly to advancing science, accelerating clinical insights, and supporting the development of life-changing therapies.

Apply today and grow your clinical data management career with Trialmed and the PPD clinical research team.