The Investigator Contracts Lead focuses on negotiating and managing clinical trial agreements, ensuring compliance, and collaborating with various stakeholders to facilitate site contracting processes.
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
REMOTE POSITION- US
Key Accountabilities:
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
Collaboration
- 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
Compliance with Parexel standards
- 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
Skills:
- 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
Knowledge and Experience:
- 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
Education:
- 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
#LI-LG4
Similar Jobs
Artificial Intelligence • Cloud • Consumer Web • Productivity • Software • App development • Data Privacy
The Senior Product Manager will manage the product strategy and execution for team expansions on Dropbox, enhance collaboration features, analyze usage metrics, and improve user engagement through effective cross-functional collaboration.
Top Skills:
B2B Saas
Blockchain • eCommerce • Fintech • Payments • Software • Financial Services • Cryptocurrency
Design and build scalable data ingestion pipelines and modernize Block's CDC platform while collaborating cross-functionally to ensure data flows reliably for analytics and ML initiatives.
Top Skills:
Apache IcebergApache KafkaAWSDatabricksDelta LakeGoJavaKafka ConnectPythonScalaSnowflakeTerraform
Cloud • Security • Software • Cybersecurity • Automation
As a Solutions Architect, you will advise financial services clients on using GitLab's AI-powered DevSecOps platform, driving digital transformation and ensuring compliance. Your role includes leading technical evaluations, collaborating with sales teams, and maintaining relationships with clients to foster GitLab adoption.
Top Skills:
AICloud ComputingDevsecopsGitlab
What you need to know about the Toronto Tech Scene
Although home to some of the biggest names in tech, including Google, Microsoft and Amazon, Toronto has established itself as one of the largest startup ecosystems in the world. And with over 2,000 startups — more than 30 percent of the country's total startups — Toronto continues to attract new businesses. Be it helping entrepreneurs manage their finances, simplifying business operations by automating payroll or assisting pharmaceutical companies in launching new drugs, the city's tech scene is just getting started.
