Clinical Business Liaison Site Contracts and Budgets FSP 50 office based in Burlington, Ontario
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Job Location:
Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.
Job Summary:
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.
Key Responsibilities
Clinical Trial Budget Management
- 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 $to over $10 million
Clinical Trial Contract Development and Execution
- 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
Stakeholder Collaboration
- 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
Cross-Functional Collaboration
- 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
Qualifications
Education
- Bachelors degree in Life Science or Business is required
Experience
- 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
Key Skills
- Presentation Skills
- Time Management
- Clinical Research
- Communication skills
- GCP
- Infusion Experience
- Managed Care
- Hospice Care
- Conflict Management
- Clinical Trials
- Research Experience
- Home Care
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
