Description
We are seeking a Contracting Specialist to develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs.
Responsibilities:
- Develop and coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.
- Develop contract language, payment language and budget templates as required.
- Utilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs.
- Ensure collaboration with sponsors, stakeholders and RSU regions and countries to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
- Provide specialist legal, operational and financial contracting support to the Study Teams.
- Assist with the creation and/or review of core scientific, technical and administrative documentation.
- Contribute to the collection, interpretation, analysis and dissemination of accurate contracting intelligence.
- Ensure overall contracting efficiency and adherence to project timelines and financial goals.
- Report contracting performance metrics and out of scope contracting activities.
- Work with Quality Management to ensure appropriate contract management and quality standards.
- Mentor and coach colleagues as required.
- Deliver presentations to clients as required.
Qualifications:
- Bachelor's Degree in a related field.
- 5 years of relevant sponsor or clinical research organization clinical site contracting experience.
- Good negotiating and communication skills.
- Strong legal, financial and/or technical writing skills.
- Strong understanding of regulated clinical trial environment and knowledge of drug development process.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Strong knowledge of Microsoft Office and e-mail applications.