Clinical Data Associate II
Location: Bangalore, Karnataka, India
Job ID: R-01324178
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.) is dedicated to advancing clinical trials that address the world’s most pressing health challenges. We combine scientific expertise with meticulous execution to support the development of innovative therapies.
Work Schedule: Second Shift (Afternoons) – 1:00 PM to 10:00 PM IST
Work Environment: Adherence to all GMP Safety Standards; flexible work mode (onsite, remote, or hybrid).
Job Description:
The Clinical Data Associate II (CDA) will act as a supporting data manager on one or more projects, ensuring high-quality, compliant, and timely data management in alignment with project protocols. You will contribute to clinical research excellence by overseeing key data processes, ensuring data accuracy, and facilitating project success.
Key Responsibilities:
Identify, resolve, and update data discrepancies in the data management database.
Generate, track, and resolve data clarifications and queries; contribute to CRF design where applicable.
Review data listings for accuracy and consistency; address data validation and reporting issues.
Prepare and deliver project-specific status reports to management and clients.
Perform Serious Adverse Event and Third-Party Vendor reconciliations, along with data listing reviews.
Execute advanced data cleaning activities in accordance with GCP and SOP/WPD requirements.
Handle complex assignments requiring strong judgment, initiative, and problem-solving skills.
Act as a facilitator or informal team leader when necessary, engaging with internal and external stakeholders effectively.
Education & Experience:
Bachelor’s degree or equivalent formal academic qualification.
Minimum 2+ years’ 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 standards.
Excellent attention to detail, numerical accuracy, and proficiency with Microsoft Office.
Strong written and verbal communication skills in English.
Analytical and problem-solving abilities, with moderate supervision.
Ability to adapt quickly to new tools, including Generative AI.
Strong interpersonal and cultural awareness skills for effective global collaboration.
Experience with EDC systems (Medidata Rave, Veeva Vault) and good documentation practices (eTMF).
Knowledge of clinical trial terminology, project protocols, and Data Validation Manual.
Commitment to confidentiality and high ethical standards in handling clinical data.
Estimated Salary Range: ₹7 LPA – ₹10 LPA (Based on experience and expertise)
Gujarat :
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