Clinical Budgets and Contracts Liaison

Job Title: Clinical Procurment Manager
Location: Burlington, Ontario

Type: 12 Month Contract (renewable)
Contractor Work Model: Hybrid

Clinical Procurment Manager
Location: Hybrid, Metro Toronto - 50% on site monthly


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 relationships with internal and external customers in a manner that consistently meets the organization’s expectations.
• Ability to see issues from the customer’s perspective, assesses urgency of requests and responds accordingly.
• Focus on fulfilling expectations by seeking insight into customer needs and developing solutions that provide value.

Knowledge:



Technical/systems: Within 6 months demonstrates a working or functional proficiency level associated with technical/systems required to oversee clinical trials.

Clinical Research Environment : At entry, demonstrates a working or functional understanding of the requirements of the clinical research environment (Sponsor, Investigator and Regulatory).

SOP/Guidelines: Within 6 months demonstrates a clear understanding and ability to reference as appropriate



Special Skills:



Legal/contractual and budgetary activities:

• Demonstrates in depth understanding of legal/contractual activities and budgeting for clinical studies; at entry demonstrates at least a minimal proficiency level of contractual and budgetary requirements, within 6 months demonstrates a working or functional proficiency level
• Strong financial and business acumen. At entry demonstrates at least a minimal financial and business understanding for clinical trial business requirements; within 6 months demonstrates a working or functional proficiency level of business related aspect of clinical trials.
• Excellent negotiation; At entry demonstrates at least a minimal contract negotiation proficiency level, within 6 months demonstrates a working or functional proficiency level for negotiating clinical contracts
• Highly developed analytical and problem solving skills and excellent mentoring and leadership skills.
• Advance knowledge of PC software: Demonstrates working and functional proficiency of programs such as MS Word, Excel and PowerPoint.

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M-
#LI-
#DI-

Ref: #568-Clinical