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Sr Clinical Data Associate

Thermo Fisher Scientific
Thermo Fisher Scientific
3+ years
Not Disclosed
10 Dec. 15, 2025
Job Description
Job Type: Full Time 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

Senior Clinical Data Associate

Location: Mumbai, Maharashtra, India
Job ID: R-01331305
Employment Type: Full-Time
Category: Clinical Research | Data Management | Pharmacovigilance
Work Mode: Fully Remote / Hybrid / Office-Based


About the Role

Thermo Fisher Scientific is seeking a Senior Clinical Data Associate (Sr. CDA) to join Trialmed, a global site network and early-phase clinical research solution for PPD. This role offers a unique opportunity to lead high-impact data management projects, ensuring the accuracy, integrity, and regulatory compliance of clinical trial data.

As a Senior Clinical Data Associate, you will act as a supporting data manager across one or more clinical studies, managing complex datasets, ensuring strict adherence to protocols, and contributing to process improvement initiatives on a global scale.


Key Responsibilities

Clinical Data Management

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

  • Identify, resolve, and update data discrepancies in the clinical data management system.

  • Generate, track, and resolve data queries and clarifications; implement CRF design as required.

  • Review data listings for accuracy, consistency, and compliance with project protocols.

  • Perform advanced data cleaning and reconciliation activities, including Serious Adverse Event (SAE) and third-party vendor reconciliations.

  • Contribute to global process improvements for clinical data management.

Leadership & Mentorship

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

  • Provide guidance, training, and work direction to junior data associates.

  • Serve as a facilitator or informal team leader on complex projects.

Reporting & Communication

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

  • Interact with global teams, external partners, and stakeholders with professionalism, tact, and cultural awareness.

  • Communicate effectively regarding complex data issues, recommendations, and solutions.


Education & Experience Requirements

  • Bachelor’s degree or equivalent academic qualification in Life Sciences, Pharmacy, or related field.

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

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


Required Skills & Competencies

  • Strong knowledge of clinical trial terminology, protocols, and data validation procedures.

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

  • Knowledge of good documentation practices, including eTMF.

  • High attention to detail, numerical proficiency, and analytical skills.

  • Excellent written and verbal communication in English.

  • Ability to work independently or within a team environment with moderate supervision.

  • Adaptable and fast learner, capable of integrating new information and tools, including Generative AI.

  • Strong organizational and time management skills, with the ability to prioritize multiple tasks.

  • Commitment to confidentiality and data integrity in clinical research.


Work Environment

  • Working Hours: 1:00 PM – 10:00 PM IST, Monday to Friday

  • Flexibility to work remotely, hybrid, or office-based.

  • Adherence to Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) safety standards.