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Years of Experience
Date Last Verified
Legal Contracts Associate I The candidate will manage and is accountable for the work of professional level employees within the Study Start-up function. Will develop investigator grant budgets according to protocol specifications and local requirements. Populate clinical trial agreements, ancillary agreements and other documents and distribute the same to sites. Negotiate clinical trial agreements and ancillary agreements within the approved negotiation parameters. Negotiate the budget and payment terms within the scope of the approved negotiation parameters. Liaise with the Study Start up Project Lead, Site Contract Coordinator and any other stakeholders as required in accordance with inVentiv Health Clinical SOPs. Work with Legal Lead assigned to each study and the sponsor to obtain timely approval of any changes that are outside of approved negotiation parameters during the contracting process. Manage the translation of site comments, requests and amendments during the contracting process. Review and communicate any known issues with translations provided by translation vendor. * Ensure quality checks of the final deliverables before submitting a contract for signature as per the Contract Plan. Provide regular local status updates to the parties designated in the Contract Plan, which may be the SSU Project Lead, PM or Legal Lead. Update the designated study specific study-tracking tools and update the global inVentiv tracking tool as required per group practice and the Contract Plan. File and archive documents in accordance with approved processes. Distribute executed agreements to appropriate stakeholders in a timely manner. Identify and escalate issues identified during the contract negotiation process that could affect quality and timeliness of the site contracting deliverables or that could impact client or site relations. Attend project team calls. May perform other duties as assigned.
Qualification and Experience
The candidate should have Bachelor degree preferably in Business or Law or equivalent combination of education, training and experience. Must have 1+ year of experience in managing the contractual process in a similar position with relevant experience in clinical research. Must have strong organizational skills. Must have demonstrate good computer skills. Fluency and ability to translate documents and review translation in local language and English required. Excellent communication, presentation, interpersonal skills, both written and spoken is required.
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