Investigator Contracts Lead I
Investigator Contracts Lead I
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Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.
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
Submits expense reports as
Updates CV as
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
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:
Bachelors 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
Employment Type
Full-Time
