• Advise study teams on the country specific characteristics related to site contracts, for the client sponsored study of any complexity, including contribution to site selection process and site prioritization activities;
• Supporting as Lead Contract Manager, one point of contact for multiple studies
• Prepare, distribute, negotiate, and drive to execution site contracts Clinical Trial/Study Agreements or Study Letter if Master Agreement is in place) with the appointed Clinical Research Organization (“CRO”) or affiliate or directly with the site as appropriate
• Escalate to appropriate sponsor colleague when a significant risk to the business is identified
• Independently make appropriate business decisions within their scope of authority and educate internal project leaders on the issues and risks associated with contracting and/or budget decisions.
• Ensure that clinical contracts are negotiated within the Fair Market Value in accordance to guidelines and SOPs.
• Identify potential risks and manage issue resolution of high complexity.
• Ensures status reports are provided to appropriate parties both internally and externally on a regular basis.
• Evaluate changes, identify business and/or legal risk associated with such changes and escalate relevant requests to either legal and/or business partners and/or line managers as appropriate proposing alternative solutions or feedback to facilitate the review.
• Evaluate changes requested within contracts, identify business and/or legal risk associated with such changes and escalate relevant requests to either legal team leads and/or business partners and/or line managers as appropriate proposing alternative solutions or feedback, whenever possible, to facilitate the review.
• Participate in the drafting and/or revision of the contract templates, when necessary, escalating to legal team leads.
• Escalate issues when needed and encourage resolution at the lowest appropriate level.
• Drive department specific initiatives and projects regionally or globally
• Create back-up and or mitigation plans in order to get in front of potential specific risks within the department
• Requires minimal supervision
• Capitalize on strengths of relationships/networks to effectively work with cross functional teams and influence these teams as necessary