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

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: Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing

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

Location: Client-Based / India
Company: Syneos Health
Job Type: Full-Time
Work Mode: Client-Based / Home-Based (as per project requirement)
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 Strongly Preferred


About the Company

Syneos Health is a globally recognized clinical research organization (CRO) and biopharmaceutical solutions company supporting pharmaceutical, biotechnology, and healthcare innovators throughout the drug development lifecycle. The company delivers expertise in clinical trial management, regulatory compliance, clinical operations, centralized monitoring, and global study execution.

This role is ideal for experienced clinical research professionals seeking senior opportunities in clinical operations, CTMS management, trial master file oversight, centralized monitoring, clinical project coordination, and sponsor-facing study operations.


Job Overview

Syneos Health is hiring a Senior Clinical Operations Specialist / Lead Clinical Operations Specialist for a client-based opportunity in India. This position is best suited for experienced clinical operations professionals with 7–10 years of Clinical Trial Associate (CTA) and clinical study management experience, preferably with exposure to centralized monitoring.

The selected candidate will support global clinical trial execution, study documentation management, CTMS updates, TMF oversight, budget coordination, vendor collaboration, study tracking, and operational clinical research support.

This is an excellent opportunity for senior professionals looking to advance into leadership-focused clinical operations roles within a global CRO environment.


Key Responsibilities

Clinical Trial Operations Management

  • Support operational execution of clinical studies from startup through closeout.
  • Maintain accurate information in Clinical Trial Management Systems (CTMS) and associated clinical systems.
  • Update study timelines, project milestones, ethics committee approvals, and health authority authorizations.
  • Track ongoing clinical trial progress and ensure operational accuracy across study systems.

Trial Master File (TMF) Management

  • Support setup, maintenance, and quality oversight of the Trial Master File (TMF).
  • Ensure essential clinical documents are properly maintained, complete, and inspection-ready.
  • Follow up with clinical trial teams for timely TMF document management.
  • Maintain compliance with sponsor and regulatory documentation standards.

Clinical Project & Budget Support

  • Assist Senior Clinical Project Managers with:
    • Clinical study budget tracking
    • Financial planning support
    • Grant plan monitoring
    • Vendor financial reconciliation
    • Goods receipt booking activities
  • Support financial operational reporting aligned with study progress.

Vendor & External Service Provider Coordination

  • Support onboarding and coordination of external service providers.
  • Ensure all documentation, systems access, and study materials are in place.
  • Monitor day-to-day vendor activities and operational deliverables.
  • Ensure timely communication between service providers and study teams.

Clinical Monitoring & Operational Oversight

  • Support centralized monitoring and clinical oversight activities where applicable.
  • Review operational data, identify issues, and escalate findings to project leadership.
  • Address operational questions, study risks, and documentation concerns proactively.
  • Support study quality monitoring and compliance initiatives.

Study Coordination & Team Support

  • Assist in:
    • Study startup activities
    • Recruitment coordination
    • Clinical study closeout
    • Internal and sponsor meetings
    • Meeting documentation and reporting
    • Project documentation preparation
  • Maintain effective coordination across internal clinical teams.

Operational Excellence

  • Support process improvements, transitions, and workflow enhancements.
  • Ensure project deliverables are completed within agreed timelines.
  • Maintain proactive communication with leadership and stakeholders.

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 Trial Associate (CTA) / Clinical Operations experience
  • Strong understanding of:
    • Clinical trial operations
    • CTMS platforms
    • TMF documentation
    • Clinical project coordination
    • Budget tracking
    • Vendor management
    • GCP compliance
  • Strong English communication skills
  • Proactive and solution-driven mindset
  • Excellent organizational and coordination abilities
  • Ability to manage multiple clinical projects