*Serve as single point of contact for contracts and related budgets.
*Responsible for managing the coordination, negotiation, and finalization of contracts/agreements, associated modifications and cost justification for clinical trials.
*Review clinical study protocols and develop site budgets using Medidata Grants Manager costing tool to ensure the scope of work is defined correctly and the budget accurately reflects the scope.
*Meet with clinical study teams to review and discuss study budget negotiation parameters.
*Develop study budget templates with selected fair market value costs.
*Review, customize and format clinical study site contracts/agreements and payment terms.
*Distribute study site contracts/agreements and budgets to clinical study sites.
*Lead negotiation of contracts/agreements and budgets with clinical sites.
*Facilitate and follow internal contract review and approval process with Legal department and sign-off authority.
*Responsible for the entry of executed contracts/agreements into the CLM database in a timely manner to facilitate the tracking of the review and approval process.
*Return executed original contracts/agreements to clinical study sites.
*Archive executed original contract/agreements in the trial master file.
*Provide accurate updates on all outstanding contractual documents to management as required.
*Prepare and maintain trackers, reports and metrics relating to the contract process timelines and costs.
*Maintain a working knowledge of the departmental processes, associated procedural documents, and ICH
Good Clinical Practice (GCP) guidelines.
*Set priorities and bring conflicting priorities to CTBO Management for assistance in resolving.
*Work within the department's metrics/timelines for completion of documents.
*Train and mentor junior team members on departmental processes and companywide directives.
*Proactively recognize and assist in resolution of departmental related issues as required.
*Perform additional responsibilities as assigned and support other department projects as requested.
*Minimum of 2 - 3 years in clinical research/pharmaceutical or CRO industry with clinical trial contract and budget specific experience.
*Minimum of a High School Diploma or GED, Bachelors Degree or equivalent work experience within industry preferred.
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