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Global drug and device development services

Site Specialist - Contracts & Budgets

Clinical Research OperationsPosted on Nov 11
Full-timeChennai, Tamil Nadu, IndiaNo salary listed

About the Job

Requirements

  • Bachelor’s degree in Life Sciences or a related discipline, or equivalent relevant experience
  • 3+ years' experience negotiating and managing clinical trial contracts and site budgets within a pharmaceutical, biotech, or CRO environment
  • Strong understanding of regulatory and compliance requirements for clinical trials across jurisdictions
  • Demonstrated ability to manage multiple priorities, set clear timelines, and deliver within deadlines in a fast-paced environment
  • Excellent analytical, communication, and interpersonal skills, with the ability to confidently explain legal and financial concepts to diverse stakeholders
  • High attention to detail with a strong track record of risk identification and mitigation
  • Experience mentoring or supporting junior team members, with the ability to work both independently and collaboratively within cross-functional teams

Responsibilities

  • Leading the negotiation, execution, and ongoing management of Clinical Trial Agreements (CTAs) and site budgets with investigative sites
  • Collaborating with Clinical Operations and Project Management teams to support timely site activation, including forecasting and tracking contract execution timelines
  • Partnering with Functional Management to ensure adherence to local laws, regulatory requirements, and departmental policies, minimizing legal and operational risk
  • Supporting study start-up activities, including coordination of translations and assisting with submission packages for Central and Local Ethics Committees/Institutional Review Boards and Competent Authorities
  • Reviewing and evaluating client-requested contract changes, assessing deviations, escalating when required, and applying departmental guidelines to decision-making
  • Prioritizing and managing multiple contracts simultaneously, adapting to shifting timelines and business needs
  • Proactively identifying and escalating risks or issues to the CTA Lead, FSA PM, CTM, or Contract Manager to ensure smooth project progression
  • Ensuring contracts and amendments are complete, accurate, compliant with internal standards, and appropriately filed within contract databases
  • Maintaining clear and timely documentation of all site interactions and contract status updates
  • Mentoring and guiding junior Contract Associates, supporting their professional growth and development
  • Continuously identifying opportunities to enhance processes, strengthen collaboration with project teams and investigative sites, and improve overall service delivery
  • Providing strategic insights and recommendations to CTA Leads and Project/Functional Management to enhance team efficiency and responsiveness

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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