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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)

Location: Hyderabad or Gurgaon, India (Hybrid)
Job ID: 25104013
Updated: December 3, 2025

About the Company

Syneos Health is a leading integrated biopharmaceutical solutions organization providing clinical development, medical affairs, and commercial services. With more than 29,000 employees across 110 countries, the company is committed to accelerating the delivery of new therapies by uniting scientific expertise with operational excellence.

Role Overview

The Senior Site Activation Specialist is responsible for delivering high-quality site start-up activities at the country level for clinical trials. This role ensures compliance with regulatory requirements, manages essential documentation, supports ethics and regulatory submissions, and contributes to efficient site initiation and activation. The position requires strong operational expertise, independent decision-making, and the ability to collaborate with cross-functional teams.

This position can be based in Hyderabad or Gurgaon and follows a hybrid work model.

Key Responsibilities

General Responsibilities

  • Ensure high-quality deliverables for country-level site start-up activities with minimal oversight from the SSU Country Manager.

  • Forecast submission and approval timelines, track progress in real-time, and escalate delays with data-driven rationales and contingency plans.

  • Monitor financial aspects of assigned projects, including hours and tasks per contract.

  • Maintain compliance with SOPs, Work Instructions, training records, and timesheet requirements.

  • Ensure complete and timely submission of essential documents to the Trial Master File (TMF) in accordance with company standards.

  • Support continuous improvement initiatives within Site Start-Up (SSU) operations.

  • Participate in vendor management when assigned.

Local Submission Responsibilities

  • Act as the primary point of contact for the Project Manager/Site Activation Manager during study start-up.

  • Compile, review, and submit essential document packages for site activation.

  • Prepare and submit Central and Local Ethics Committee applications, Regulatory Authority submissions, and other required approvals.

  • Manage ongoing submissions, amendments, and safety notifications in alignment with local regulations.

  • Facilitate communication between investigational sites and functional leads.

  • Oversee the end-to-end site activation process at the country and site level.

Country Start-Up Advisory

  • Serve as a subject matter expert for country-specific regulatory and start-up requirements.

  • Maintain up-to-date regulatory intelligence and ensure central repository updates.

  • Provide guidance on data protection statements and adapt sponsor-provided documents to meet local regulatory expectations.

  • Contribute to local SOPs, internal training materials, and quality improvement initiatives.

  • Support issue resolution with Ethics Committees or Competent Authorities.

Site Identification and Feasibility

  • Support the site selection process by ensuring site suitability and alignment with study requirements.

Investigator Contract and Budget Negotiation (as required)

  • Prepare site-specific contracts based on country templates.

  • Negotiate budgets and contract terms with sites and relevant stakeholders.

  • Manage contract execution, quality control, and archiving of documents.

Leadership and Mentoring

  • Provide guidance to junior team members on administrative policies, technical tasks, and operational priorities.

  • Participate in interviews, training, performance reviews, and team development initiatives.

  • May serve as Country Delivery Lead to support operational delivery, monitor site metrics, and enhance project efficiency.

Summary of Role Purpose

Responsible for all assigned country-level activities supporting site start-up across all phases of clinical trials. This includes contract negotiations, ethics and regulatory submissions, essential document management, and ensuring timelines, budgets, and quality standards are met. May interface directly with Regulatory Authorities and Ethics Committees and may serve as Country Start-Up Advisor or Site Activation Manager for local/regional projects.

Experience and Qualification Requirements

Education

  • Bachelor’s degree in life sciences, pharmacy, healthcare, or related field is required.

Experience

  • Required experience:

    • Minimum 4–7 years of experience in Site Start-Up, Regulatory Affairs, Clinical Operations, or Clinical Research within a CRO, pharmaceutical company, or clinical research environment.

    • Experience in ethics and regulatory submissions, essential document management, and site activation.

    • Prior experience in contract and budget negotiations is preferred.

    • Demonstrated experience working independently on country-level submissions.

Skills and Competencies

  • Strong knowledge of local regulatory requirements (EC/RA processes).

  • Proven ability to manage timelines, multitask, and adapt to dynamic project needs.

  • Excellent organizational, communication, and documentation skills.

  • Attention to detail and ability to work with minimal supervision.

  • Proficiency with Microsoft Office and clinical trial management systems.

  • Experience interacting with investigational sites and regulatory bodies.

  • Ability to provide mentorship and support team development.

Work Environment

  • Hybrid work model based in Hyderabad or Gurgaon.

  • Requires cross-functional collaboration and potential interaction with global teams.

  • Additional responsibilities may be assigned based on business needs.

Equal Opportunity Statement

Syneos Health is committed to fostering an inclusive, diverse, and equitable work environment. Applicants with transferable skills or related experience are encouraged to apply, even if not meeting every listed qualification.

How to Apply

Interested candidates may apply through the application link provided on The Pharma Daily. Applicants can also join the Syneos Health Talent Network to stay informed about future opportunities.