Senior Site Contract Specialist – Sponsor-Dedicated
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Job Description
Senior Site Contract Specialist optimizing clinical research support for biopharmaceutical sponsor. Developing and managing clinical trial agreements, budgets, and financial aspects for successful execution.
Responsibilities:
- Develop, negotiate, and execute Clinical Trial Agreements (CTAs), amendments, budgets, and related study documents.
- Manage clinical trial budgets throughout the study lifecycle, including budget development, negotiation, forecasting, and payment processing.
- Serve as a key business liaison between Clinical Operations, Finance, Legal, Procurement, FSP partners, vendors, and investigative sites.
- Provide expertise and guidance on study contract and budget management to internal stakeholders.
- Analyze study requirements and develop creative contracting and compensation solutions that support site participation and protocol execution.
- Manage financial aspects of clinical study contracts and budgets utilizing Veeva Clinical Contracts & Payments and grant tracking systems.
- Collaborate cross-functionally to implement processes, work instructions, and guidelines that align with business objectives and sponsor expectations.
- Identify contractual, operational, and financial risks and proactively develop solutions.
- Support multi-country contracting activities and ensure compliance with sponsor requirements, ICH-GCP guidelines, and Health Canada regulations.
- Maintain accurate contract documentation, reporting, milestone tracking, and Trial Master File (TMF) records.
- Contribute to process improvements, best practices, and training initiatives within Site Start-Up and Clinical Operations.
Requirements:
- Bachelor’s degree in Business, Public Health, Life Sciences, Finance, or a related field, or equivalent experience.
- 3–5 years of experience in clinical research, site contracts, budgets, or contract management within a CRO, pharmaceutical, or biotechnology environment.
- Strong knowledge of Clinical Trial Agreements (CTAs)
- Clinical trial budgets and negotiations
- Clinical trial start-up processes
- ICH-GCP and Health Canada requirements
- Experience managing site contracts, budgets, and financial aspects of clinical studies.
- Strong communication, negotiation, problem-solving, and stakeholder management skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Proficiency in Microsoft Office Suite.
- Experience with Veeva Clinical Contracts & Payments and grant tracking systems.
- Experience working in a Sponsor-Dedicated/FSP model.
- Knowledge of clinical trial payment processes and study forecasting.
- Experience supporting process improvement initiatives and mentoring junior team members.
Benefits:
- We are passionate about developing our people, through career development and progression;
- Supportive and engaged line management;
- Technical and therapeutic area training;
- Peer recognition and total rewards program;
- Committed to building an inclusive culture – where you can authentically be yourself.
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