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Sr Site Activation Specialist (Hyderabad/Gurgaon)

4-7 years
Not Disclosed
10 Dec. 5, 2025
Job Description
Job Type: Full Time Hybrid 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

Senior Site Activation Specialist – Hyderabad / Gurgaon (Hybrid)

Syneos Health**

Location: Gurugram / Hyderabad, India
Job Type: Hybrid
Job ID: 25104013
Updated On: December 3, 2025


About Syneos Health

Syneos Health is a fully integrated biopharmaceutical solutions organization focused on accelerating clinical, medical affairs, and commercial outcomes. With a presence across 110 countries and a workforce of more than 29,000 professionals, the company is committed to transforming clinical development by keeping patients and customers at the center of all operations.

The organization fosters a culture that supports authenticity, growth, and continuous learning, offering extensive training, career development pathways, and global collaboration.


Position Overview

The Senior Site Activation Specialist is responsible for managing and executing activities that drive the start-up and activation of investigative sites for clinical trials. The role ensures compliance with regulatory requirements, project timelines, and quality standards within India. This position interacts with cross-functional teams, regulatory authorities, and investigative sites to ensure seamless execution of start-up processes.


Key Responsibilities

1. Regulatory and Ethics Submissions

  • Prepare, review, and submit applications to Central and Local Ethics Committees, Competent Authorities, and other regulatory bodies.

  • Manage ongoing submissions, protocol amendments, safety notifications, and periodic updates.

  • Maintain up-to-date regulatory intelligence and ensure compliance with country-specific legislation.

2. Essential Document Management

  • Compile, review, and finalize essential document packages required for site initiation.

  • Ensure timely submission of documents into the Trial Master File (TMF) according to SOPs and sponsor requirements.

3. Site Activation Oversight

  • Coordinate end-to-end site activation activities at the country and site level.

  • Support feasibility assessments and site identification to ensure the selection of appropriate investigative sites.

  • Track project milestones and forecast approval timelines, addressing delays with mitigation plans.

4. Contract and Budget Negotiation

  • Prepare site-specific Clinical Trial Agreements (CTAs) based on country templates.

  • Negotiate budgets and contracts with sites in collaboration with internal contract management teams.

  • Ensure proper execution and archiving of contracts and associated metadata.

5. Cross-Functional Liaison

  • Act as a point of contact for Project Leads, Site Activation Managers (SAMs), and investigational sites.

  • Provide country-level expertise on study start-up processes and regulatory requirements.

  • Support vendor management where applicable.

6. Quality, Compliance, and Documentation

  • Maintain timesheet accuracy, SOP compliance, and training records.

  • Ensure adherence to data protection guidelines and confidentiality requirements.

  • Support continuous improvement initiatives at the country level.

7. Leadership and Mentorship (If Assigned)

  • Mentor junior staff and support management functions such as interviewing, professional development, and performance feedback.

  • May act as Country Delivery Lead and oversee portfolio-level start-up performance.


Required Qualifications and Experience

  • Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related field.

  • Experience:

    • Minimum 4 to 7 years of experience in Site Start-Up, Regulatory Affairs, Clinical Operations, or related functions within the clinical research industry.

    • Strong understanding of ICH-GCP guidelines, ethics committee submissions, and regulatory processes.

  • Skills Required:

    • Expertise in EC/RA submissions

    • Strong documentation and quality compliance skills

    • Ability to manage timelines and work independently

    • Proficiency in site contract and budget negotiations

    • Strong communication and stakeholder coordination abilities

  • Preferred: Experience interacting with Indian regulatory authorities and familiarity with hybrid work environments.


Work Environment

  • Hybrid model with office presence in Gurugram or Hyderabad.

  • Collaboration with global and regional cross-functional teams.

  • High-performance environment with opportunities for career advancement.


Summary

The Senior Site Activation Specialist plays a critical role in ensuring smooth and efficient clinical trial start-up across assigned studies in India. This position requires strong regulatory knowledge, documentation accuracy, communication skills, and the ability to manage complex timelines. The role may also include mentoring responsibilities and acting as a subject matter expert for country-level start-up processes.