Job Title:
Senior Data Operations Technical Specialist
Location:
Hyderabad, India
Job ID:
25101764
Company Overview:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization. The company accelerates customer success by translating clinical, medical affairs, and commercial insights into actionable outcomes, with patients and customers at the center of its Clinical Development model.
Learn more: Syneos Health
Job Summary:
The Senior Data Operations Technical Specialist supports Data Management (DM) teams in delivering technical solutions, meeting study deliverables, and integrating new technologies within Data Operations. The role provides subject matter expertise, develops specifications, monitors quality standards, and mentors staff to ensure efficient and compliant operations.
Core Responsibilities:
Support development of specifications for technical DM processes and systems.
Contribute to RFP and RFI processes and participate in proposal bid defense meetings.
Act as Subject Matter Expert (SME) for designated systems/databases used by DM.
Ensure processes and best practices are maintained globally and consistently.
Assist in monitoring productivity, quality standards, and project metrics.
Identify potential out-of-scope work and support Lead Clinical Data Manager (LCDM).
Participate in internal, sponsor, third-party, and investigator meetings.
Support audits, inspections, and compliance activities.
Develop User Test Plans for data entry screens, edit checks, data listings, import/export programs, and medical coding.
Support release of tested clinical 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 development of departmental technologies, SOPs, processes, and procedures.
Participate in testing and integration of new technologies within Data Operations.
Maintain ongoing documentation and ensure proper TMF filing.
Train and mentor DM staff.
Maintain proficiency in DM systems and processes; attend professional meetings/conferences.
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 education and experience considered.
6+ years of experience in EDC Build and Setup, including specification writing, UAT, listing creation, protocol understanding, and system architecture.
Expertise in EDC systems: Rave / Veeva.
Strong mentoring skills with the ability to explain technical processes clearly.
Effective communication, presentation, and interpersonal skills.
Strong organizational, planning, and time management abilities.
Ability to multitask and meet tight deadlines while maintaining attention to detail.
Flexible, adaptable, and capable of working independently or as part of a global multidisciplinary team.
Positive attitude and strong teamwork skills.
Knowledge of ICH/GCP regulatory requirements for clinical studies.
Skills & Competencies:
Technical expertise in Data Management systems and processes.
Ability to design, implement, and improve DM processes.
Mentorship and leadership capabilities.
Strong analytical and problem-solving skills.
Proficiency in training, documentation, and audit support.
Impact & Contribution:
Ensures efficient and compliant Data Management operations.
Provides SME guidance and training to staff.
Supports process improvement, technology integration, and project delivery.
Job Category:
Data Operations / Clinical Data Management / EDC
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