Senior Clinical Data Associate – Remote, Mumbai, India
Location: Mumbai, Maharashtra, 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 Trialmed network, is seeking a Senior Clinical Data Associate (Sr CDA) to join our global Clinical Research team. This role offers a unique opportunity to manage and support world-class data management projects across early phase clinical trials, ensuring accurate, compliant, and timely delivery of clinical data.
The Sr CDA will serve as a supporting data manager for one or more studies, emphasizing data integrity, regulatory compliance, and adherence to Good Clinical Practices (GCP). You will collaborate with global teams, lead complex data activities, and contribute to the optimization of clinical data management processes.
Key Responsibilities
Support setup of study activities including database design, data entry screen testing, and Data Validation Manual (DVM) creation.
Identify, resolve, and update data discrepancies within the data management database.
Generate, track, and resolve data queries; implement CRF designs as required.
Review data listings for accuracy and consistency; analyze and resolve validation and data management reports.
Act as subject matter expert for study-specific processes and provide guidance to junior staff.
Contribute to global data management process improvements and best practices.
Produce project-specific status reports for Clinical Data Management (CDM) management and clients.
Perform advanced data cleaning processes, including Serious Adverse Event (SAE) and third-party vendor reconciliations.
Work independently on complex assignments, demonstrating judgment, initiative, and problem-solving skills.
Facilitate communication with external stakeholders, ensuring professionalism, tact, and effective collaboration.
Required Qualifications & Experience
Education: Bachelor’s degree or equivalent in a scientific or health-related field.
Experience: Minimum 3+ years in clinical data management or related roles.
Demonstrated experience with EDC systems, particularly Medidata Rave and Veeva Vault.
Knowledge of Good Clinical Practice (GCP), global SOPs, and regulatory guidelines.
Strong understanding of medical/clinical trial terminology, project protocols, and Data Validation Manuals.
Proven ability to work independently or collaboratively in a global team environment.
Skills & Competencies
Exceptional attention to detail, analytical, and problem-solving skills.
Proficiency in Microsoft Office Suite and interactive computer programs.
Strong written and verbal communication skills with excellent command of English.
Agile learner, capable of adopting generative AI tools and new technologies for data management.
High degree of professionalism and confidentiality in handling clinical and proprietary data.
Effective time management, organization, and prioritization in a fast-paced environment.
Cultural awareness and ability to interact effectively with global stakeholders.
Work Schedule & Environment
Standard working hours: 1:00 PM – 10:00 PM IST
Flexible work options: office, remote, or hybrid.
Adherence to all Good Manufacturing Practices (GMP) safety standards and global regulatory compliance.
Why Join Thermo Fisher Scientific
At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. Join a global team of professionals driving early phase clinical trials and contributing to life-changing therapies worldwide. We value diverse perspectives, innovation, and collaboration, offering opportunities for professional growth and career advancement.
Equal Opportunity Employer: Thermo Fisher Scientific is committed to creating a diverse and inclusive workforce and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected status.
SEO Keywords Optimized: Senior Clinical Data Associate India, Clinical Data Management Jobs Mumbai, Remote Clinical Data Associate, EDC Specialist Medidata Rave, CRO Data Management Careers.
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