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Sr Clinical Data Associate

3+ years
Not Disclosed
10 Nov. 12, 2025
Job Description
Job Type: 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 (Sr CDA)

📍 Location: Global / Remote / Hybrid Options (India Time Zone)
🕒 Work Hours: 1:00 PM – 10:00 PM IST
🏢 Organization: Trialmed – Early Phase Clinical Solution for PPD, the clinical research business of Thermo Fisher Scientific Inc.
💼 Employment Type: Full-Time


About Trialmed

Trialmed, part of Thermo Fisher Scientific’s PPD clinical research business, is a global site network delivering early-phase clinical solutions. We empower scientific breakthroughs by combining innovation, data excellence, and operational precision. Joining our team means contributing to a mission of making the world healthier, cleaner, and safer through quality data management and clinical excellence.


Role Overview

As a Senior Clinical Data Associate (Sr CDA), you will support and lead clinical data management activities across one or more global studies. You will ensure data integrity, accuracy, and compliance while collaborating with global cross-functional teams. This position emphasizes flawless project execution, quality delivery, and process improvement within the data management lifecycle.


Key Responsibilities

Study Setup & Database Management

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

  • Identify, investigate, and resolve data discrepancies, implementing necessary updates in databases.

  • Generate, track, and resolve data clarifications and queries; may assist in CRF design using graphic design tools.

Data Review & Quality Control

  • Review data listings for accuracy, consistency, and completeness.

  • Perform data validation, Serious Adverse Event (SAE), and Third-Party Vendor reconciliations.

  • Execute data cleaning activities with high accuracy, in compliance with GCP, SOPs, and WPDs.

Process Improvement & Leadership

  • Act as subject matter expert (SME) for study-specific processes.

  • Provide training, guidance, and mentorship to junior team members.

  • Contribute to the continuous improvement of global data management standards and tools.

Communication & Reporting

  • Prepare and deliver project-specific status reports to CDM management and clients.

  • Collaborate effectively with internal and external stakeholders to resolve data issues.

  • Represent the team in cross-functional discussions requiring tact, persuasion, and negotiation.


Education & Experience

  • Education: Bachelor’s degree or equivalent qualification in Life Sciences, Computer Science, or a related field.

  • Experience: Minimum 3+ years of experience in Clinical Data Management or related areas.

  • A combination of education, training, and relevant experience may be considered.


Knowledge, Skills, and Abilities

  • Strong knowledge of GCP, clinical trial processes, and data management principles.

  • Experience with EDC systems such as Medidata Rave and Veeva Vault.

  • Excellent command of English (written and verbal) and professional communication skills.

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

  • Proficiency in Microsoft Office Suite and interactive software tools.

  • Ability to manage multiple priorities, meet timelines, and work both independently and collaboratively.

  • Understanding of medical terminology, protocols, and data validation manuals.

  • Adherence to confidentiality and good documentation practices (eTMF).

  • Agile learner, comfortable adapting to new tools and technologies, including Generative AI.


Working Conditions

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

  • Work Mode: Flexible — Office-based, Remote, or Hybrid options available.