Primary Location: Poland, Remote
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Job ID R0000034911
Category Clinical Trials
ABOUT THIS ROLE
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.
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.
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