Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Clinical Data Associate Ii (Inform)

Syneos Health
Syneos Health
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