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SR. Contracts Manager: MedFocus
    SR. CONTRACTS MANAGER
COMPANY INFO: MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel. Our client creates new standards of care in therapeutic areas with high unmet medical needs and is seeking to add a Sr. Contracts Manager to their team in San Diego, CA. RESPONSIBILITIES: • Responsible for complex contract negotiation and management of vendors and for site contracting in multiple clinical development programs (Ph1-IV). Develops site study budget with a costing tool, manages site payments via CTMS, updates a central database for contract tracking purposes, juggles competing priorities, and tracks metrics. Fully proficient in vendor contracting; scope of work/budgets/contract negotiations and investigator budgeting; direct/indirect fees and Third party payers. • In particular, negotiating CDA’s, Master Clinical Trial Agreements, Work Orders, Change Orders and Start Up Agreements. Outsourcing Site Contracting: managing the CRO for outsourcing of site agreements and payments. • Timely negotiation and execution of vendor and site contracts is critical for the start of clinical trials. Effectively produce and manage vendor contracts and site budgets and appropriate review/negotiation of vendor/site contracts to minimize significant legal and/or financial risk; effective communication and performance related to vendor/site contracting for good relations with vendors/clinical trial institutions. Liaise directly with study management teams (SMT’s), Legal, Finance, external service providers and investigator site personnel, including Investigators. Works directly with SMT’s with minimal supervision from more senior staff. Can make decisions regarding contract management but may seek validation/input from more senior staff. Provides input into best practices and looks for efficiencies in interactions between study management teams, external service providers and Clinical Trial Institutions. QUALIFICATIONS: • In depth understanding of MSA’s, Work Orders, MCTA’s and budgets, commercial language including, specific legal terminology; client’s position on business and legal terms, and when legal support is required, new ways of working, ability to influence within and across project teams. Capable of decision making that will impact overall vendor/site budgets, drives vendor selection process; RFP to Award; perform strategic review of study timelines and work independently to meet timelines without specific requests from SMT. • Proficient in advanced Excel, CTMS and document comparison software. • BS/BA; Master's preferred; Preferred in Business or Health Care related field; 3 years relevant experience in the pharmaceutical industry. MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.
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