Job Specifications
Job Title: Clinical Budgets and Contracts Liaison
Location: Burlington, Ontario
Type: Contract
Compensation: $45 CAD hourly
Contractor Work Model: Hybrid
January Start
12 months contract+
Job Description:
Accountabilities
Clinical Trial Budget Management
To effectively manage external budgets for assigned studies including budget development, budget negotiation, processing payments and forecasting for the full life cycle of the clinical trial.
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 FMV process in budget development for all studies
Clinical Trial Contract development and execution.
Develop legally sound external contracts through timely and cost effective negotiations.
Develop investigator/institution contracts, consultant agreements and grants.
Negotiate with investigators and institutions representatives to finalize study contracts.
Ensure the all contracts are in place prior to planned site initiations.
Alignment with ICH/GCP and Health Canada requirements
Providing expertise to internal stakeholders for study contract and budget management
Manage the financial aspects of all clinical study contracts and budgets by 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 committee
Works with team members and FSP Partners to analyze study requirements and define creative contracting solutions that maximize ability of sites to execute trial protocols.
Minimizes the risk exposure to business and maximize business viability and integrity.
Regulatory and / or Organizational Requirements
Identifies, develops and works cross functionally with other business functions (e.g. finance, purchasing, legal, vendors, FSP partners, clinical operations) to implement guidelines, working instructions and processes in accordance with customer expectations and corporate objectives.
Job Complexity
Responsible for working to collaborate across a broad spectrum or stakeholders. Must be able to work in a highly complex institutional type environments when negotiating contracts and budgets.
Interfaces:
Client: Finance, Legal, Medical Affairs, DRA, Pharmacovigilance.
Corporate Functions: CTLs, CTMs, TMMs External customers: CROs, Vendors (e.g. benchmarking data)
Job Expertise
Working to expert knowledge of contracting concepts, applicable regulations, and legal terminology.
3+ years practical experience in Clinical Contracting environment.
Job Impact
Responsible for development and management of trial budgets and payments, amount is dependent on specific trials. Range from 1,000,000 to over $10 million dollar trials.
Minimum Education/Degree Requirements
Bachelor's degree in Life Science or Business
Required Capabilities (Skills, Experience, Competencies)
Communication:
Entry level: Developing 2 years: Demonstrating
Ability to communicate clearly, correctly, knowledgeably, and effectively both verbally and in writing.
Uses appropriate methods of communication to achieve desired results.
Ability to communicate effectively to groups, varying style to fit the audience, actively communicating with those with differing opinions and differing levels of understanding.
Problem Solving:
Entry level: Developing 2 years: Demonstrating
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. Using original ideas and combining with historical approaches to go beyond traditional solutions. Ability to identify issues, obstacles, and opportunities and then develop and implement effective solutions.
Project Management:
Entry level: Developing 2 year: Demonstrating
Prioritizes plans and timelines based on potential risk identification and monitors a course of action;
Recognize the impact of tasks/risks to other team members and sites; understands and aligns regulatory requirements with contractual obligations.
Accountability:
Entry level: Developing 2 years: Demonstrating
Clearly defines mutual expectations of self and others
Takes appropriate actions to ensure obligations are met in a timely manner.
Shows ownership for personal decisions and actions in all situations
Takes accountability for mistakes and is open to sharing lessons learned
Accepts accountability for team deliverables where appropriate
Teamwork and Collaboration:
Entry level: Developing 2 years: Demonstrating
Ability to establish and maintain effective
About the Company
At Joule, we believe our world is filled with possibilities - where character, integrity, and commitment drive our purpose. For over 30 years, Joule has been a trusted partner to industry-leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent. Operating at the forefront of the life sciences arena, Joule's relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects. Joule is a System One division.
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