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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