Job Title: Senior Clinical Data Associate (Sr CDA)
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25001154
Updated: February 13, 2025
Company Overview:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. With 29,000 employees across 110 countries, we aim to simplify clinical development by putting customers and patients at the center of our work.
Why Work Here:
We prioritize career development, progression, and supportive management.
We value diversity and inclusivity in our workplace culture (Total Self culture).
We offer training, peer recognition, and a rewards program to foster growth.
Key Responsibilities:
Project Management:
Maintain awareness of contracts and scope of work, providing regular status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM).
Review and adhere to study-specific Data Management Plans (DMP) and update as required.
Data Management:
Perform User Acceptance Testing (UAT) for data entry screens, data review listings, and Source Data Verification (SDV) configuration.
Complete and submit access forms for Clinical Database Management Systems (CDMS).
Perform quality checks on data entered into clinical databases and resolve discrepancies through queries or self-corrections.
Review Data Clarification Forms (DCFs) and edit CRF databases as required.
Quality Control:
Perform internal quality control checks on paper studies and Electronic Data Capture (EDC) systems.
Lead the validation of SAS mapping and discrepancy resolution.
Collaboration & Communication:
Liaise with other teams such as Clinical Programming, Biostatistics, and Clinical Operations.
Attend in-process review meetings and participate in internal/external audits.
Communicate updates effectively to the team, sponsors, and clients.
Training & Mentoring:
Mentor and train junior Data Management staff.
Provide EDC training to internal and external team members.
Documentation:
Review, update, and create study-specific documents such as CRF/eCRF DMP and data import/export agreements.
Ensure all documentation is accurately filed in the Data Management Study File (DMSF).
Qualifications:
Education:
BA/BS degree in biological sciences or related disciplines in the natural science/healthcare field.
Experience:
Experience in clinical research, drug development, data management, or a healthcare-related environment is preferred.
Experience with Oracle Clinical, Rave, or Inform systems is advantageous.
Technical Skills:
Proficiency in MS Windows, Word, Excel, and email applications.
Familiarity with medical terminology and clinical data management practices.
Communication & Leadership:
Strong communication, presentation, and interpersonal skills.
Proven leadership skills with the ability to mentor and guide junior team members.
Ability to handle multiple tasks under tight deadlines with high attention to detail.
Additional Information
Minimal travel may be required (up to 25%).
The company is committed to diversity, equity, and inclusion.
How to Apply
If you're interested in this opportunity, please submit your application via the Syneos Health website.
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