Clinical Data Associate II (CDA II)
Updated: November 27, 2024
Location: India - Asia Pacific - IND-Home-Based
Job ID: 24006412
Job Description
Overview
Syneos Health® is a global biopharmaceutical solutions leader, dedicated to accelerating customer success through integrated clinical, medical, and commercial insights. We place the customer and the patient at the center of our work, continually innovating to deliver meaningful outcomes.
Our Total Self culture embraces authenticity and diversity, ensuring an inclusive and supportive workplace where Work Here Matters Everywhere.
Why Syneos Health?
Career Development: Ongoing learning through technical training, career progression opportunities, and mentorship.
Inclusive Culture: Celebrate diversity in thoughts, backgrounds, and experiences to foster innovation and belonging.
Recognition & Rewards: Competitive benefits and peer recognition programs support our employees’ contributions and well-being.
Key Responsibilities
As a Clinical Data Associate II, your contributions will include:
Maintaining awareness of project contracts and scope of work.
Adhering to study-specific Clinical Data Management Plans (DMPs).
Conducting User Acceptance Testing (UAT) for data entry screens, edit checks, and review listings.
Managing discrepancy (edit check) outputs, resolving queries, and applying corrections based on Data Validation Specifications (DVS).
Handling data received from external datasets (e.g., lab data, electronic diaries, PK data) and ensuring consistency with the clinical database.
Conducting internal QC checks for both electronic and paper studies.
Performing Serious Adverse Event (SAE) reconciliations and interim data reviews.
Creating test data for Standard Data Tabulation Model (SDTM) and running data-cleaning/status reports.
Collaborating on SAS mapping quality checks and documenting discrepancies.
Coordinating with and training other Clinical Data Associates (CDAs) as needed.
Participating in audits, team meetings, and training sessions to ensure compliance with corporate practices and SOPs.
Proactively communicating timelines, availability, and task progress to the project team and management.
Qualifications
Education: BA/BS in biological sciences, healthcare, or a related discipline.
Experience: Preferred background in clinical research, drug development, or data management, with familiarity in medical terminology.
Systems Knowledge: Experience with Oracle Clinical, Rave, or Inform systems is a plus.
Technical Proficiency: Advanced skills in MS Office, strong keyboard accuracy, and familiarity with relational database management systems.
Skills:
Excellent written and verbal communication.
Strong organizational, multitasking, and time management abilities.
Flexibility to adapt to dynamic priorities and work both independently and as part of a team.
Attention to detail and proactive problem-solving capabilities.
Join Us
Syneos Health has supported 94% of FDA-approved drugs in the past five years, partnering with leading innovators to impact global health. Be part of a passionate team that drives transformative results in clinical research.
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Syneos Health is committed to creating an inclusive workplace. If your experience doesn’t align perfectly, we encourage you to apply anyway, as we value diverse perspectives and transferable skills.
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