Essential Functions
1. Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.
2. Develop contract language, payment language and budget templates as required as applicable to the position
3. Utilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.
4. Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
5. Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
6. Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreements
7. Report contracting performance metrics and out of scope contracting activities as required.
8. Work with Quality Management to ensure appropriate contract management and quality standards. Mentor and coach colleagues as required including the delivery of training materials as required.
Qualifications
9. Bachelor's Degree Related field OR 5-year relevant sponsor or clinical research organization clinical site contracting experience
10. Good negotiating and communication skills with ability to challenge.
11. Strong legal, financial and/or technical writing skills.
12. Strong understanding of regulated clinical trial environment and knowledge of drug development process.
13. Good understanding of clinical trial contract management.
14. Fluent in English and German language
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