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Clinical Programmer Ii

0-2 years
Not Disclosed
10 April 3, 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

 


Clinical Programmer II (Rave/Veeva)

Company: Syneos Health
Location: India
Experience: Experience in clinical programming and EDC systems (Rave, Veeva, Oracle Inform)

About Syneos Health

Syneos Health is a leading biopharmaceutical solutions provider, with 29,000 employees across 110 countries, focused on accelerating clinical development and improving patient outcomes.

Join us—because work here matters everywhere.


Job Summary

The Clinical Programmer II will be responsible for designing, developing, validating, and maintaining clinical programming solutions using Medidata Rave, Veeva, Oracle Inform, SAS, and PL/SQL. This role requires expertise in Electronic Data Capture (EDC) systems and clinical database programming.


Key Responsibilities

Clinical Programming & Data Management

  • Develop, validate, and maintain clinical databases and programming solutions using:

    • Oracle RDC, Oracle Inform, Medidata Rave, Veeva Vault

    • SAS, PL/SQL, C#, and VB

  • Generate and maintain required documentation, including:

    • CRF annotations, database specifications, edit check procedures, imports/exports, and custom reports

  • Perform quality control (QC) and validation of study-level deliverables

  • Ensure compliance with ICH guidelines, regulatory requirements, and sponsor specifications

Project Coordination & Leadership

  • Lead clinical programming activities for multiple projects (up to 8 studies)

  • Act as the primary point of contact for programming-related issues

  • Monitor project timelines and scope and escalate issues as needed

  • Participate in sponsor audits and assist with in-progress audits

  • Support Quick Start Camps (QSCs) as the lead clinical programmer

Collaboration & Training

  • Provide technical guidance, training, and mentorship to junior programmers

  • Work closely with clinical data management teams, sponsors, and project leads

  • Assist in budget reviews and track work scope for change orders

Process Improvement & Compliance

  • Keep up-to-date with industry trends, programming techniques, and regulatory changes

  • Support the development of best practices, SOPs, and programming standards

  • Ensure data integrity and compliance with FDA, EMA, and CDISC guidelines


Qualifications & Skills

Education & Experience

  • Bachelor’s degree preferred (or equivalent education and experience)

  • Strong experience in clinical programming and Electronic Data Capture (EDC) systems

  • Experience working in a matrix-structured environment

Technical & Industry Knowledge

  • Proficiency in Oracle RDC, Oracle Inform, Medidata Rave, and Veeva Vault

  • Programming experience with PL/SQL, SAS, C#, or VB (preferred)

  • Strong understanding of clinical data management and regulatory compliance

Soft Skills

  • Excellent communication and interpersonal skills

  • Strong analytical and problem-solving abilities

  • Ability to manage multiple projects and deadlines

Additional Requirements

  • Ability to travel up to 25% as needed


Why Join Syneos Health?

  • Worked on 94% of all Novel FDA-Approved Drugs in the past five years

  • Collaborated on 95% of EMA-Authorized Products and 200+ studies across 73,000 sites

  • Competitive career growth, mentorship, and rewards program

  • Be part of a diverse, inclusive, and innovative workplace


Join Us

If you have relevant experience, apply now or join our Talent Network for future opportunities at Syneos Health.