Senior Site Contract Specialist – Sponsor-Dedicated

This is a fully remote position, open to applicants in Canada.

📋 Description

• Design, negotiate, and implement Clinical Trial Agreements (CTAs), amendments, budgets, and associated study documents.

• Oversee clinical trial budgets across the study lifecycle, encompassing budget creation, negotiation, forecasting, and payment processing.

• Act as a primary business representative between Clinical Operations, Finance, Legal, Procurement, FSP partners, vendors, and investigative sites.

• Offer expertise and direction on study contract and budget management to internal stakeholders.

• Evaluate study requirements and devise innovative contracting and compensation solutions that facilitate site participation and protocol execution.

• Manage the financial components of clinical study contracts and budgets using Veeva Clinical Contracts & Payments and grant tracking systems.

• Work collaboratively across functions to establish processes, work instructions, and guidelines that are in line with business goals and sponsor expectations.

• Recognize contractual, operational, and financial risks and proactively formulate solutions.

• Assist with multi-country contracting activities, ensuring conformity with sponsor requirements, ICH-GCP guidelines, and Health Canada regulations.

• Keep precise contract documentation, reporting, milestone tracking, and Trial Master File (TMF) records.

• Contribute to process enhancements, 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.

• Comprehensive knowledge of Clinical Trial Agreements (CTAs).

• Familiarity with clinical trial budgets and negotiation processes.

• Understanding of clinical trial start-up procedures.

• Knowledge of ICH-GCP and Health Canada regulations.

• Experience in managing site contracts, budgets, and financial aspects of clinical studies.

• Excellent communication, negotiation, problem-solving, and stakeholder management abilities.

• Capability to handle multiple priorities in a dynamic environment.

• Proficient in Microsoft Office Suite.

• Experience with Veeva Clinical Contracts & Payments and grant tracking systems.

• Background in working within a Sponsor-Dedicated/FSP model.

• Knowledge of clinical trial payment processes and study forecasting.

• Experience in supporting process improvement initiatives and mentoring junior team members.

🏝️ Benefits

• We are dedicated to developing our team members through career advancement and growth opportunities;

• Supportive and engaged line management;

• Technical and therapeutic area training;

• Peer recognition and comprehensive rewards program;

• Committed to fostering an inclusive culture where you can truly be yourself.