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Contract Specialist Ii/Sr. Site Contract Specialist

0-2 years
Not Disclosed
10 Oct. 4, 2025
Job Description
Job Type: Full Time 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

🧑‍💼 Position Title:

Contract Specialist II / Sr. Site Contract Specialist


🌍 Location:

IND-Client


🆔 Job ID:

25101892


🎯 Job Overview:

Responsible for managing and executing site contract activities for industry-sponsored clinical trials. Ensures contracts and budgets are prepared, negotiated, and executed in compliance with regulations, SOPs, and project requirements. Acts as the primary liaison between investigative sites, sponsors, and internal teams while mentoring junior staff.


🌟 Key Responsibilities:

🔹 Contract & Budget Management

  • Lead multi-country projects including negotiating and preparing contracts, budgets, and related documents.

  • Produce and review site-specific contracts from country CTA templates.

  • Submit proposed CTA and investigator budget for site review.

  • Negotiate budgets and contracts with sites, sponsors, and service centers until resolution.

  • Perform quality control and ensure execution and archival of CTAs.

  • Administer all contract management processes, including coordination with protocol, informed consent, institutions, investigators, vendors, consultants, and sponsors.

🔹 Process & Compliance

  • Ensure contracts are complete, accurate, and aligned with SOPs and internal procedures.

  • Identify operational risks and propose solutions.

  • Track milestone progress in the SSU tracking system and maintain real-time updates.

  • Monitor financial aspects of projects and escalate discrepancies.

  • Contribute to development and review of contract templates, budget templates, SOPs, and WIs.

🔹 Stakeholder & Vendor Coordination

  • Work closely with Site Contract Service Center, Legal, SSU Lead, Clinical Operations, and Finance teams.

  • Facilitate execution of contracts by company signatories.

  • Serve as key liaison between internal and external customers, providing functional guidance.

  • Represent site contracts/SSU in internal or customer meetings.

🔹 Leadership & Mentorship

  • Train and mentor less experienced staff on SOPs, WIs, and workflow processes.

  • Maintain and update training materials for site contract team.

  • Provide quality feedback and guidance to peers.

  • Participate in discussions about departmental and company goals, objectives, and project aims.


🎓 Qualifications & Requirements:

  • BA/BS degree in Business Administration, Public Administration, Public Health, or related field; advanced degree preferred.

  • Moderate contracts management experience in CROs or pharmaceutical industry; management experience preferred.

  • Strong knowledge of clinical development processes, legal, and contracting parameters.

  • Excellent understanding of clinical trial process across Phases II–IV and ICH GCP guidelines.

  • Project management experience in fast-paced environments.

  • Strong organizational, vendor management, negotiation, and problem-solving skills.

  • Excellent communication, presentation, and interpersonal skills.

  • Ability to mentor and motivate junior staff.

  • Proficient in Microsoft Office Suite.


🌐 Why Syneos Health:

  • Inclusive Total Self culture promoting diversity, belonging, and professional growth.

  • Work with global teams across 29,000 employees in 110 countries.

  • Opportunity to impact FDA-approved and EMA-authorized drug studies.


📌 Summary:

The Contract Specialist II / Sr. Site Contract Specialist manages site contracts and budgets, ensures compliance with SOPs and regulations, coordinates with internal and external stakeholders, tracks milestones, and provides mentorship to junior staff. The role contributes to the efficiency, accuracy, and timely execution of site contract and start-up processes for clinical trials.