Senior Clinical Data Associate (Sr CDA) – Clinical Research
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Data Management
Job ID: R-01331312
Work Model: Fully Remote | Second Shift (Afternoons)
About the Role
Join Thermo Fisher Scientific, through its PPD® clinical research portfolio, as a Senior Clinical Data Associate (Sr CDA) at Trialmed, our global early-phase clinical site network. This position provides an exceptional opportunity to lead world-class data management initiatives that advance clinical research on a global scale.
As a Sr CDA, you will act as a supporting data manager for multiple projects, ensuring high-quality data handling, adherence to project protocols, and delivery of accurate clinical insights that support drug development and patient safety.
Key Responsibilities
Lead setup of study activities, including database design, testing of data entry screens, and creation of Data Validation Manuals (DVMs).
Identify, resolve, and update data discrepancies, ensuring integrity of clinical databases.
Generate, track, and resolve data clarifications and queries, including potential CRF design adjustments.
Review data listings and validation reports for accuracy, consistency, and compliance with GCP and SOPs.
Serve as a subject matter expert for specialized study-specific processes.
Provide training and guidance to junior staff and ensure adherence to best practices.
Contribute to global process improvements in clinical data management.
Prepare project-specific status reports for CDM management and clients.
Perform advanced data cleaning tasks with high accuracy to assess safety and efficacy of investigational products.
Execute complex assignments independently, applying judgment and problem-solving skills.
Collaborate with internal and external stakeholders, including global teams, to ensure effective communication and project success.
May serve as a team lead or facilitator on assigned projects.
Required Qualifications & Experience
Education: Bachelor’s degree or equivalent formal academic qualification in a relevant scientific or clinical discipline.
Experience: Minimum 3+ years in clinical data management or a related field.
Proven experience with EDC/DM databases, such as Medidata Rave and Veeva Vault, and familiarity with eTMF and good documentation practices.
Combination of education, training, and relevant experience may be considered sufficient.
Skills & Competencies
Strong attention to detail and numerical accuracy.
Excellent written and verbal communication skills, with strong command of English.
Analytical and problem-solving abilities; capable of working productively with moderate supervision.
Quick learner, adaptable to new tools, workflows, and Generative AI-assisted platforms.
Ability to work independently or collaboratively with cross-functional global teams.
Understanding of clinical trial terminology, protocols, and Data Validation Manual standards.
High level of confidentiality and professionalism in handling clinical and proprietary data.
Strong time management and organizational skills to handle multiple priorities.
Working Conditions
Standard working hours: 1:00 PM to 10:00 PM IST
Flexibility to work remote, hybrid, or office-based, depending on business needs.
Why Join Us
Become a part of Trialmed and Thermo Fisher Scientific, where your expertise in clinical data management directly contributes to developing life-changing therapies and improving global health outcomes. Work on complex, high-impact projects in a collaborative, innovative, and supportive environment.
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