Clinical Business Liaison - Site Contracts and Budgets - FSP - 50% office based in Burlington, Ontario

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Optimizes clinical research support activities by providing smart business solutions to complex contractual, compensation and payment structures thereby achieving success in all business aspects of Clinical Operations.

• Develop budgets for clinical trials according to protocol requirements
• Forecast trial budgets in line with corporate timelines
• Review clinical trial budgets prior to submission to corporate for reimbursement
• Ensure Rx&D code of conduct principles are incorporated into all applicable contractual agreements
• Uphold the global Fair Market Value (FMV) process in budget development for all studies
• Manage external budgets for assigned studies including budget development, negotiation, processing payments and forecasting for the full life cycle of clinical trials
• Responsible for development and management of trial budgets and payments ranging from $1,000,000 to over $10 million

• Develop investigator/institution contracts, consultant agreements and grants
• Develop legally sound external contracts through timely and cost-effective negotiations
• Negotiate with investigators and institution representatives to finalize study contracts
• Ensure all contracts are in place prior to planned site initiations
• Maintain alignment with ICH/GCP and Health Canada requirements

• Manage the financial aspects of all clinical study contracts and budgets through expert knowledge of Veeva Clinical and Payment module and Grant Tracking system
• Participate in clinical trial working group meetings including corporate task forces
• Contribute to innovation by participating on local task forces and committees
• Work with team members and FSP Partners to analyze study requirements and define creative contracting solutions that maximize ability of sites to execute trial protocols
• Minimize risk exposure to business and maximize business viability and integrity

• Work cross-functionally with other business functions (finance, purchasing, legal, vendors, FSP partners, clinical operations) to implement guidelines, working instructions and processes in accordance with customer expectations and corporate objectives
• Collaborate across a broad spectrum of stakeholders in highly complex institutional environments when negotiating contracts and budgets
• Interface with internal stakeholders including Finance, Legal, Medical Affairs, DRA, Pharmacovigilance, CTLs, CTMs, TMMs
• Manage relationships with external customers including CROs and vendors

• Bachelor's degree in Life Science or Business is required

• 3+ years practical experience in Clinical Contracting environment in a CRO or Pharma organization negotiating clinical site contracts and budgets required
• Working to expert knowledge of contracting concepts, applicable regulations, and legal terminology
• Within 6 months demonstrates working or functional proficiency with technical/systems required to oversee clinical trials
• Working or functional understanding of the requirements of the clinical research environment (Sponsor, Investigator and Regulatory)
• In-depth understanding of legal/contractual activities and budgeting for clinical studies
• Strong financial and business acumen
• Excellent negotiation skills
• Highly developed analytical and problem-solving skills
• Excellent mentoring and leadership skills
• Advanced knowledge of PC software including MS Word, Excel and PowerPoint
• Ability to establish and maintain effective relationships with internal and external customers
• Ability to prioritize contract/budget issues and use creative thinking to solve conflicting priorities
• Defines problems, analyzes causes, identifies possible solutions, selects the best solution, and develops action plans
• Ability to use creative thinking to improve processes and solve complex problems