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