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Senior Clinical Operations Specialist / Lead Clinical Operations Specialist

Syneos Health
Syneos Health
7-10 years
preferred by company
Remote, India, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing

Senior Clinical Operations Specialist / Lead Clinical Operations Specialist – Remote Clinical Research Jobs in India | Immediate Joiner | Syneos Health

Location: Remote, India
Company: Syneos Health
Job Type: Full-Time
Work Mode: Remote / Home-Based
Department: Clinical Operations / Clinical Research / Trial Management
Experience Required: 7–10 years of relevant Clinical Trial Associate (CTA) / Clinical Operations experience
Job ID: 25108746
Joining Preference: Immediate Joiners Preferred


About the Company

Syneos Health is a globally recognized clinical research organization (CRO) and biopharmaceutical solutions company supporting pharmaceutical, biotechnology, and healthcare innovators across the full clinical development lifecycle. The company delivers specialized expertise in clinical operations, project management, regulatory compliance, medical research, and patient-focused trial execution.

This opportunity is ideal for experienced clinical research professionals seeking leadership roles in clinical operations, centralized monitoring, CTMS management, trial master file oversight, study coordination, and remote clinical trial execution.


Job Overview

Syneos Health is hiring a Senior Clinical Operations Specialist / Lead Clinical Operations Specialist for a remote India-based opportunity. This role is designed for experienced clinical research professionals with strong expertise in clinical trial coordination, CTMS management, Trial Master File oversight, centralized monitoring, study startup, vendor coordination, and operational clinical project support.

Candidates with Clinical Trial Associate (CTA) experience combined with centralized monitoring expertise will be highly preferred.

The selected professional will support clinical project execution, study documentation, monitoring oversight, external vendor coordination, data review activities, and operational excellence across global clinical research programs.


Key Responsibilities

Clinical Trial Operations Management

  • Support end-to-end clinical trial operational activities across study startup, execution, monitoring, and closeout.
  • Maintain accurate updates in Clinical Trial Management Systems (CTMS) and related clinical systems.
  • Track study timelines, milestones, ethics committee approvals, and regulatory authorizations.
  • Ensure operational readiness for assigned clinical studies.

Trial Master File (TMF) Management

  • Support setup, maintenance, and quality oversight of the Trial Master File (TMF).
  • Ensure all essential study documents are accurately filed and audit-ready.
  • Follow up with clinical trial teams for timely TMF completeness and compliance.
  • Maintain documentation integrity aligned with sponsor and regulatory expectations.

Clinical Project Support & Budget Coordination

  • Assist Clinical Project Managers in study budget planning, financial tracking, grant planning, and reporting.
  • Support vendor invoice reconciliation and financial documentation workflows.
  • Help monitor project risks, timelines, and operational deliverables.

Vendor & External Service Provider Coordination

  • Support onboarding, setup, and coordination of external service providers.
  • Ensure documentation, systems, and operational readiness for study execution.
  • Coordinate day-to-day vendor communication and issue resolution.
  • Ensure timely reporting of operational data to clinical teams.

Centralized Monitoring & Data Oversight

  • Perform central monitoring activities using clinical data systems such as:
    • eCRF
    • IRT
    • Central Lab systems
    • Trial monitoring dashboards
  • Review clinical data for:
    • Completeness
    • Plausibility
    • Data consistency
    • Protocol deviations
    • Safety alerts
    • Quality risks
    • Trend analysis
  • Escalate critical findings to clinical teams and CRAs.
  • Support centralized risk-based monitoring activities.

Clinical Data Review & Safety Collaboration

  • Collaborate with Medical Leads and study teams to identify safety trends.
  • Participate in Data Review Team (DRT) discussions.
  • Support preparation of central monitoring packages for CRAs.
  • Assist in issue tracking and action follow-up.

Study Coordination & Team Support

  • Support study startup, recruitment, execution, and closeout processes.
  • Coordinate meetings, documentation, reporting, and internal communications.
  • Prepare meeting minutes, operational reports, and project documentation.
  • Assist with onboarding internal and external study teams.

Operational Excellence

  • Support implementation of operational improvements, transitions, and process enhancements.
  • Maintain proactive communication with stakeholders.
  • Escalate risks and project concerns in a timely manner.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Clinical Research
    • Nursing
    • Medicine
    • Allied healthcare disciplines
  • 7–10 years of relevant Clinical Operations / CTA experience
  • Strong understanding of:
    • Clinical trial operations
    • CTMS systems
    • TMF management
    • Centralized monitoring
    • Clinical data oversight
    • GCP compliance
    • Vendor coordination
  • Strong communication skills in English
  • Proactive and solution-oriented mindset
  • Excellent project coordination skills
  • Ability to work independently in remote clinical environments