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Clinical Data Associate Ii (Inform)

0-2 years
Not Disclosed
10 April 1, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 Title: Clinical Data Associate II (Inform)

Updated: March 26, 2025
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002256


Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success through clinical, medical affairs, and commercial insights.

  • Global Presence: 29,000 employees across 110 countries

  • Commitment to Employees: Career development, training, peer recognition, and a Total Self culture

  • Industry Impact: Worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products in the past 5 years


Job Responsibilities

Clinical Data Management

  • Maintain awareness of project contracts and scope

  • Follow study-specific Clinical Data Management Plans (DMPs)

  • Conduct User Acceptance Testing (UAT) for data entry screens and validation checks

  • Enter and verify lab normal ranges

  • Perform discrepancy review and validation checks to ensure data integrity

  • Manage Clinical Database Management System (CDMS) access

  • Process Data Clarification Forms (DCFs) and update databases accordingly

Quality Control & Compliance

  • Conduct internal QC checks for both electronic and paper studies

  • Ensure Electronic Data Capture (EDC) systems comply with standards

  • Participate in internal/external audits and meetings

  • Store and manage Data Management Study Files (DMSF)

Data Processing & Reconciliation

  • Ensure data consistency from external sources (e.g., labs, PK data, IRT systems)

  • Conduct Serious Adverse Event (SAE) reconciliations

  • Understand and implement data coding processes

Coordination & Communication

  • May coordinate work of Clinical Data Associates (CDAs)

  • May train others in data management activities

  • Prioritize multiple tasks and adapt to timeline changes


Qualifications & Requirements

Education & Experience

  • Bachelor’s degree in biological sciences, natural sciences, or a related healthcare field

  • Preferred Experience: Clinical data management, drug development, or healthcare environment

Technical Skills

  • Knowledge of Data Management (DM) practices & relational database software

  • Experience with Inform systems preferred

  • Proficiency in MS Windows, Word, Excel, and email applications

  • Familiarity with ICH/Good Clinical Practices (GCP) and medical terminology

Soft Skills

  • Strong communication, presentation, and interpersonal skills

  • Organized and detail-oriented, with the ability to multitask under deadlines

  • Flexibility and adaptability to changing priorities


Additional Information

  • Minimal travel required (up to 25%)

  • Syneos Health is committed to equal opportunity employment and diversity

  • The company reserves the right to modify job responsibilities as needed


How to Apply

  • Apply directly through Syneos Health’s career portal

  • Join the Talent Network to stay updated on career opportunities