Contracts Associate II Study Start-Up

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Contracts Associate II (Study Start-Up)
The candidate will be responsible for the commercial relationship with sites involved in clinical trials including work from contract and amendment language, budget negotiation within the established timeline parameters. Will ensure the successful negotiation and on-going management of clinical trial agreements with investigative sites. Work cross functionally with Clinical Operations and Project Management in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines. Collaborate with the Functional Manager who will partner with other compliance departments to ensure country specific laws and regulations are followed to minimize risk in clinical trials. Communicate and explain legal/ budgetary issues to internal and external parties per department guidelines. Review and evaluate client requested contract changes and based upon department guidelines escalates deviations as appropriate. In partnership with CTA Lead and others as necessary, evaluate priorities and quickly readjust priorities with the changing needs of business and the client. Identify and proactively raises issue to the CTA Lead or CM, as appropriate, prior to their becoming critical or creates risk. Appraise contracts for completeness and accuracy and ensure adherence to department guidelines; correct documents and files changes to contracts. Participate in client meetings for the purpose of expediting the contract signing process as directed. Create and maintain files for each contract. Generate ideas and solutions to improve requested contract/budget changes while appropriately partnering with Functional Manager and/or CTA Lead for feedback and execution. Enhance skill at discerning and responding to issues at sites that pose risk and escalating accordingly. Elevate to CTA Lead role on studies for which they provide support to CA's and PA's assigned to study, including mentoring and ensuring that all sites are handled in accordance with department guidelines. Bachelor's degree or international equivalent is required. J.D. or advance degree is preferred. Must have 1-2 years of experience with contracts. Should have 1 year of relevant experience involving contracts, negotiation, or sales in a CRO. Familiarity with working in service industry or project management environment is needed.

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