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Senior Data Operations Technical Specialist

6+ years
Not Disclosed
10 Sept. 17, 2025
Job Description
Job Type: Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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:

Senior Data Operations Technical Specialist

Location:

Remote – India

Job ID:

25101764


Company Overview:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. The company prioritizes patients and customers in its Clinical Development model while streamlining processes for efficiency and impact.

Learn more: Syneos Health


Job Summary:

The Senior Data Operations Technical Specialist supports Data Management (DM) teams in meeting technical deliverables for clinical studies. The role provides technical solutions, ensures process efficiency, integrates new technologies, and acts as a Subject Matter Expert (SME) for systems and databases used in Data Operations.


Core Responsibilities:

  • Develop specifications for technical DM processes and systems.

  • Contribute to RFP and RFI processes; participate in proposal bid defense meetings.

  • Act as SME for designated DM systems/databases and consult with internal teams and sponsors.

  • Ensure global consistency and best practices in DM processes.

  • Develop, monitor, and enforce productivity, quality standards, and project metrics.

  • Identify potential out-of-scope work and support the Lead Clinical Data Manager (LCDM).

  • Participate in and present at internal, sponsor, third-party, and investigator meetings.

  • Support internal and external audits and inspections.

  • Develop User Test Plans for data entry screens, edit checks, listings, import/export programs, and medical coding.

  • Support release of clinical data databases and updates to production environments.

  • Deliver departmental and project-specific technical training.

  • Support development of CRF/eCRF completion guidelines.

  • Review specifications for listings and summaries (non-statistical reporting).

  • Assist in developing departmental technologies, SOPs, processes, and procedures.

  • Participate in testing and integration of new technologies.

  • Maintain documentation and ensure correct TMF filing.

  • Train and mentor DM staff.

  • Maintain proficiency in DM systems and processes; represent the company at professional meetings.

  • Represent Data Operations in company-wide initiatives.

  • Perform other duties as assigned; minimal travel may be required (up to 25%).


Qualifications & Experience:

  • Bachelor’s degree required; Master’s degree or RN preferred. Equivalent experience considered.

  • 6+ years of experience in EDC Build and Setup: specification writing, UAT, listing creation, protocol understanding, and system architecture.

  • Expertise in EDC systems: Rave / Veeva.

  • Strong mentoring skills to explain technical processes.

  • Excellent communication, presentation, and interpersonal skills.

  • Strong organizational, planning, and time management abilities.

  • Ability to multitask and deliver under tight deadlines with attention to detail.

  • Flexible and adaptable; works independently and in a global multi-disciplinary team.

  • Positive attitude and strong teamwork skills.

  • Knowledge of ICH/GCP regulatory requirements for clinical studies.


Skills & Competencies:

  • Technical proficiency in Data Management systems and processes.

  • SME guidance and mentoring capabilities.

  • Analytical, problem-solving, and documentation skills.

  • Training delivery and audit support expertise.

  • Ability to integrate new technologies and improve DM processes.