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Site Specialist - Contracts & Budgets

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ICON
3 years
Not Disclosed
Chennai, India
10 Feb. 27, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Site Specialist – Contracts & Budgets

Job Location: Chennai, India
Work Model: Office with Flex (Hybrid)
Job Type: Full-Time
Job Requisition ID: JR145157
Industry: Clinical Research / Study Start-Up / Clinical Contracts

The Site Specialist – Contracts & Budgets is a key Study Start-Up and Clinical Operations role responsible for negotiating Clinical Trial Agreements (CTAs), managing site budgets, and ensuring timely contract execution with investigative sites. This position supports efficient site activation, regulatory compliance, and financial governance across global clinical trials.

This opportunity is ideal for experienced clinical contracts professionals with strong negotiation skills and in-depth knowledge of site-level budget management within pharmaceutical, biotechnology, or CRO environments.

Role Overview

The Site Specialist – Contracts & Budgets manages end-to-end site contract negotiations and financial agreements to support timely clinical trial start-up. The role requires close collaboration with Clinical Operations, Project Management, Regulatory teams, and investigative sites to minimize activation delays and mitigate contractual risks.

The position demands strong attention to detail, legal and financial acumen, and the ability to manage multiple site agreements simultaneously in a fast-paced clinical research setting.

Key Responsibilities

  • Lead negotiation, drafting, execution, and amendment of Clinical Trial Agreements (CTAs) with investigative sites

  • Develop, review, and finalize site budgets aligned with sponsor requirements and fair market value standards

  • Track contract execution timelines to ensure timely site activation and study milestone achievement

  • Collaborate with Clinical Trial Managers (CTMs) and Project Managers (PMs) to forecast and manage contract deliverables

  • Ensure compliance with local regulations, internal SOPs, and global clinical trial standards

  • Review client-requested contract changes, assess deviations, and escalate complex issues when required

  • Support ethics committee (EC/IRB) submission documentation and translation coordination where applicable

  • Maintain accurate documentation of contract status within contract management systems

  • Identify contractual risks and proactively implement mitigation strategies

  • Mentor junior contract associates and contribute to process improvement initiatives

  • Provide strategic insights to CTA Leads and Functional Management to improve operational efficiency

Required Experience

  • Minimum 3 years of experience in clinical trial contract negotiation and site budget management

  • Proven experience working within pharmaceutical, biotechnology, or CRO organizations

  • Strong understanding of global regulatory and compliance requirements related to clinical trial agreements

  • Experience handling multiple site contracts simultaneously in a deadline-driven environment

  • Demonstrated exposure to study start-up activities and site activation processes

Educational Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Business Administration, or related field

  • Equivalent relevant professional experience may be considered

Core Competencies and Skills

  • Strong negotiation and financial analysis skills

  • Excellent understanding of Clinical Trial Agreements (CTAs) and site budget structures

  • Knowledge of global clinical trial regulatory frameworks

  • High attention to detail with strong risk identification capabilities

  • Effective communication and stakeholder management skills

  • Ability to explain contractual and financial concepts to non-legal stakeholders

  • Strong organizational skills with the ability to manage competing priorities

  • Experience mentoring junior team members and contributing to team development

Strategic Importance of the Role

The Site Specialist – Contracts & Budgets plays a critical role in accelerating site activation timelines, ensuring financial accuracy, and minimizing legal risk in clinical research programs. Effective contract management directly impacts study start-up speed, operational efficiency, and overall project profitability.

Why Apply Through ThePharmaDaily.com

ThePharmaDaily.com connects clinical research and study start-up professionals with leading global CROs, pharmaceutical companies, and biotech organizations. If you have expertise in clinical contracts, site budgets, and regulatory compliance, this role offers strong career progression within global clinical operations.

Apply now to advance your career in Clinical Contracts, Site Budget Management, and Study Start-Up Operations.