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

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;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.</p><p>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&#39;re committed to making a difference.</p><p></p><p></p><h2>Partially Remote- Must work 50% in office- Burlington, Ontario</h2><h2></h2><h2><u>Job Summary:</u></h2><p><span>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.</span></p><p></p><h2><u>Key Responsibilities</u></h2><h3>Clinical Trial Budget Management</h3><ul><li>Develop budgets for clinical trials according to protocol requirements</li><li>Forecast trial budgets in line with corporate timelines</li><li>Review clinical trial budgets prior to submission to corporate for reimbursement</li><li>Ensure Rx&amp;D code of conduct principles are incorporated into all applicable contractual agreements</li><li>Uphold the global Fair Market Value (FMV) process in budget development for all studies</li><li>Manage external budgets for assigned studies including budget development, negotiation, processing payments and forecasting for the full life cycle of clinical trials</li><li>Responsible for development and management of trial budgets and payments ranging from $1,000,000 to over $10 million</li></ul><p></p><h3>Clinical Trial Contract Development and Execution</h3><ul><li>Develop investigator/institution contracts, consultant agreements and grants</li><li>Develop legally sound external contracts through timely and cost-effective negotiations</li><li>Negotiate with investigators and institution representatives to finalize study contracts</li><li>Ensure all contracts are in place prior to planned site initiations</li><li>Maintain alignment with ICH/GCP and Health Canada requirements</li></ul><p></p><h3>Stakeholder Collaboration</h3><ul><li>Manage the financial aspects of all clinical study contracts and budgets through expert knowledge of Veeva Clinical and Payment module and Grant Tracking system</li><li>Participate in clinical trial working group meetings including corporate task forces</li><li>Contribute to innovation by participating on local task forces and committees</li><li>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</li><li>Minimize risk exposure to business and maximize business viability and integrity</li></ul><p></p><h3>Cross-Functional Collaboration</h3><ul><li>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</li><li>Collaborate across a broad spectrum of stakeholders in highly complex institutional environments when negotiating contracts and budgets</li><li>Interface with internal stakeholders including Finance, Legal, Medical Affairs, DRA, Pharmacovigilance, CTLs, CTMs, TMMs</li><li>Manage relationships with external customers including CROs and vendors</li></ul><p></p><h2><u>Qualifications</u></h2><h3>Education</h3><ul><li>Bachelor&#39;s degree in Life Science or Business is required</li></ul><p></p><h3>Experience</h3><ul><li>3&#43; years practical experience in Clinical Contracting environment in a CRO or Pharma organization negotiating clinical site contracts and budgets required</li><li>Working to expert knowledge of contracting concepts, applicable regulations, and legal terminology</li><li>Within 6 months demonstrates working or functional proficiency with technical/systems required to oversee clinical trials</li><li>Working or functional understanding of the requirements of the clinical research environment (Sponsor, Investigator and Regulatory)</li><li>In-depth understanding of legal/contractual activities and budgeting for clinical studies</li><li>Strong financial and business acumen</li><li>Excellent negotiation skills</li><li>Highly developed analytical and problem-solving skills</li><li>Excellent mentoring and leadership skills</li><li>Advanced knowledge of PC software including MS Word, Excel and PowerPoint</li><li>Ability to establish and maintain effective relationships with internal and external customers</li><li>Ability to prioritize contract/budget issues and use creative thinking to solve conflicting priorities</li><li>Defines problems, analyzes causes, identifies possible solutions, selects the best solution, and develops action plans</li><li>Ability to use creative thinking to improve processes and solve complex problems</li></ul><p></p><p>#LI-LG4</p>