Clinical Data Associate II
Location: Bangalore, Karnataka, India
Job ID: R-01324210
Job Type: Full-time
Category: Clinical Research
Remote: Fully Remote
Our Clinical Research team at Trialmed (a global site network and the early phase clinical solution for PPD, part of Thermo Fisher Scientific Inc.) plays a vital role in bringing life-changing treatments to market. We combine scientific expertise with precision in execution to support drug development addressing some of the world’s most critical health challenges.
Work Schedule: Second Shift (Afternoons) – 1:00 PM to 10:00 PM IST
Work Environment: Adherence to all GMP Safety Standards; option to work onsite, remotely, or hybrid.
Job Description:
The Clinical Data Associate II (CDA) will lead high-quality data management activities on one or more clinical research projects. You will ensure accuracy, compliance, and timely delivery of data to support study outcomes in line with GCP, SOPs/WPDs, and client requirements.
Key Responsibilities:
Identify, resolve, and update data discrepancies in the data management database.
Generate, track, and resolve data clarifications and queries; may contribute to CRF design.
Review data listings for accuracy and consistency; resolve data validation and management reports.
Produce project-specific status reports for management and clients.
Perform Serious Adverse Event and Third-Party Vendor reconciliations, along with data listing reviews.
Execute advanced data cleaning processes with precision to support product/device safety and efficacy assessments.
Handle complex assignments independently, applying judgment and recommending process improvements.
Serve as a facilitator or team leader when required, engaging with external organizations and internal stakeholders.
Education & Experience:
Bachelor’s degree or equivalent academic qualification.
Minimum 2+ years of experience in data management or a related field.
Equivalent combination of education, training, and relevant experience may be considered.
Skills & Abilities:
Strong organizational skills with adherence to regulatory guidelines, SOPs, and client expectations.
Excellent attention to detail, numerical accuracy, and proficiency in Microsoft Office.
Strong written and verbal communication skills in English.
Good analytical and problem-solving abilities, with moderate supervision.
Fast learner with adaptability to new tools, including Generative AI.
Strong interpersonal skills, cultural awareness, and customer focus in a global team setting.
Experience with EDC systems (Medidata Rave, Veeva Vault) and good documentation practices (eTMF).
Knowledge of medical/clinical trial terminology and data validation protocols.
High level of confidentiality and discretion with clinical data.
Estimated Salary Range: ₹7 LPA – ₹10 LPA (Based on experience and skills)
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