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

Parexel • Remote (Ontario, Canada) • 1d ago

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 $1,000,000 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

Bachelor's 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