Senior Clinical Data Associate (Sr CDA) – Clinical Research
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Data Management
Job ID: R-01331303
Work Model: Fully Remote
About the Role
Thermo Fisher Scientific, through its PPD® clinical research portfolio, is seeking a Senior Clinical Data Associate (Sr CDA) to join Trialmed, our global early-phase clinical site network. This position offers a unique opportunity to contribute to world-class data management projects and advance scientific research globally.
As a Sr CDA, you will act as a supporting data manager for one or more clinical trials, ensuring precise data handling, adherence to protocols, and delivery of high-quality outputs that drive safe and effective clinical development.
Key Responsibilities
Support study setup activities, including database design, testing of data entry screens, and Data Validation Manual (DVM) creation.
Identify, resolve, and update data discrepancies, ensuring the accuracy and integrity of clinical databases.
Generate, track, and resolve data queries, including potential implementation of CRF design adjustments.
Review data listings for consistency, accuracy, and compliance with regulatory standards.
Act as a subject matter expert for specialized study-specific processes and provide guidance to junior staff.
Contribute to global data management process improvements and best practices.
Prepare project-specific status reports for CDM management and clients.
Perform data management activities such as SAE and third-party vendor reconciliations and advanced data cleaning tasks in alignment with GCP and SOPs/WPDs.
Handle complex assignments requiring judgment and initiative, proposing solutions or new procedures.
Collaborate effectively with internal and external stakeholders, demonstrating strong communication, negotiation, and interpersonal skills.
May serve as a team leader or facilitator on specialized assignments.
Required Qualifications & Experience
Education: Bachelor’s degree or equivalent in a relevant scientific or clinical discipline.
Experience: Minimum 3+ years of experience in clinical data management or a related field.
Experience with EDC/DM databases such as Medidata Rave or Veeva Vault is preferred.
Knowledge of good documentation practices (e.g., eTMF) and regulatory guidelines.
Skills & Competencies
Strong analytical, organizational, and problem-solving skills with attention to detail.
Proficiency in Microsoft Office applications and other interactive data tools.
Excellent written and verbal communication skills, including strong command of English.
Ability to adapt quickly to new tools, workflows, and environments, including Generative AI-assisted tools.
Demonstrated confidentiality and integrity in handling clinical and proprietary data.
Flexibility to work independently or collaboratively within a global, cross-functional team.
Solid understanding of clinical trial terminology, study protocols, and data validation principles.
Working Conditions
Standard working hours: 1:00 PM to 10:00 PM IST.
Flexibility to work remote, hybrid, or on-site as needed.
Join Thermo Fisher Scientific and drive innovation in clinical data management, supporting the development of life-changing therapies worldwide. Apply today and become part of our global research mission.
SEO Keywords Optimized: Senior Clinical Data Associate Remote India, Clinical Data Management Jobs India, EDC Data Manager, Medidata Rave Careers, Veeva Vault Clinical Jobs India, GCP Data Management Careers.
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