Investigator Contracts Lead - FSP
Parexel
Contract
Healthcare
Canada
Hiring from: Canada
Key Accountabilities
Contracting deliverables
Contracting deliverables
- Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelines
- Follow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials
- Work with partners to develop and oversee the global site budget process
- Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters
- Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies
- Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space
- Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space
- Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline
- Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface
- Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements
- Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teams
- Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of client business objectives
- Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Updates CV as required
- Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
- Balance of general business, compliance, finance, legal, and drug development experience
- Precise communications and presentation skills
- Ability to plan, identify and mitigate risks to site contacting timelines
- Ability to lead by influence rather than positional power to accomplish critical deliverables
- Success in working in a highly matrix based organization
- Fluency in written and spoken English is required
- Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
- Knowledge of the principles, concepts and theories in applicable business discipline
- Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred
- Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR
- Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary As a Clinical Education Specialist at STERIS, you are responsible for professional...
Healthcare
Canada
Hiring from: Canada
Location: New York City metro area FLSA Status: Exempt Job Status: Full Time Work Model: Remote Work Schedule: Monday–Friday with occasional evenings and/or weekends Vehicle Required: Yes Amount of Travel Required: 15% Positions Supervised: Community Guides Reports To: Assistant Director...
Healthcare
United States
Hiring from: United States
At Fullscript, we’re not just changing healthcare—we’re making it whole. We help 100,000+ healthcare practitioners support 10 million patients with a platform that delivers evidence-based health solutions, diagnostic support, and practitioner tools—all in one place. Healthcare today is disconnected. We’re...
Healthcare
Canada
Hiring from: Canada