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Sr Cda (Data Acquisition)

0-2 years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description:
Syneos Health is seeking a Senior Clinical Data Associate (Sr. CDA) – Data Acquisition to join its dynamic team in India. As a Sr. CDA, you will play a crucial role in managing clinical trial data by ensuring accuracy, consistency, and compliance with industry standards. Your responsibilities will include user acceptance testing (UAT), database validation, data discrepancy resolution, and participation in audits. You will also oversee data entry, verification processes, and contribute to study-specific documentation while collaborating with cross-functional teams.

Key Responsibilities:

  • Maintain awareness of project scope and contracts, providing status updates to Project Managers.
  • Review and adhere to study-specific Data Management Plans (DMP).
  • Conduct User Acceptance Testing (UAT) for data entry screens, edits, and data review listings.
  • Perform data discrepancy checks, edit validations, and implement self-evident corrections.
  • Reconcile Serious Adverse Events (SAE) and ensure consistency between external and clinical databases.
  • Lead internal meetings, attend in-process review meetings, and participate in audits.
  • Provide training and mentorship to junior Clinical Data Associates.
  • Generate data cleaning reports and execute database validation tasks.
  • Collaborate with teams such as Clinical Programming, Biostatistics, and Clinical Operations to optimize data workflows.
  • Ensure compliance with ICH-GCP standards and Syneos Health SOPs while performing daily tasks.

Qualifications:

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related disciplines.
  • Experience in Clinical Data Management (CDM) with proficiency in relational database management systems.
  • Hands-on experience with Oracle Clinical, Medidata Rave, or Inform is preferred.
  • Strong knowledge of ICH-GCP and medical terminology.
  • Proficiency in MS Office (Excel, Word, Outlook) and ability to work in a fast-paced environment.
  • Excellent organizational, analytical, and problem-solving skills.
  • Effective communication and leadership abilities with the capability to mentor junior team members.

Why Join Syneos Health?

  • Work on groundbreaking clinical trials that shape the future of medicine.
  • Opportunity to collaborate with 29,000+ employees across 110 countries.
  • A strong focus on career development, mentorship, and continuous learning.
  • A culture that values diversity, inclusion, and work-life balance.

This is a remote, home-based role in India with occasional travel (up to 25%). If you are passionate about clinical data integrity and digital transformation in healthcare, we invite you to be a part of Syneos Health’s innovative journey.