W2 contract for our direct pharma client based in East Hanover, NJ - New Jersey Duties: Direct the utilization of Contract Research Organizations (CROs), Central Labs. and Specialty Providers to assure the delivery of quality, timely and cost-effective external resources to support the Company Development pipeline. Lead projects, working groups, initiatives to ensure CPM is prepared to successfully respond to the changing needs & requirements - legal, operational, regulatory & financial - of our internal & external customers, worldwide. Assist Clinical Teams to understand outsourcing procedures, assist Clinical Teams in defining the scope of work, and in some cases define the scope of work for both original contract and contract amendments. Negotiate contract terms, scope of work, pricing and payment schedules, ensuring that the agreements with the ESPs are commercially advantageous to Company, while minimizing regulatory, legal, and financial risks through close collaboration with functional partner such as legal, Finance, QA, and functional lines Produce final contracts/amendments and secure all necessary company approvals including SOX compliance to facilitate execution of said agreements Skills: At least 5-10 years clinical outsourcing experience in Drug Development in Pharmaceutical Industry Detailed understanding of the clinical development process and very robust understanding of the management of clinical trials Demonstrated ability of completing projects on time and within budget. Excellent influencing and negotiation skills. Solid understanding of contracts (including solid legal understanding of terms and conditions). Familiar with the CRO/Central Laboratories/Reference Laboratories and Specialty Provider marketplace. Solid financial understanding (understanding of cost drivers for clinical trials) as it relates to contracts and cost reductions. Excellent interpersonal skills (team player). Education: Bachelor's Degree / PhD, MBA or equivalent desirable. Required experience: clinical outsourcing / procurement: 5 years clinical development / drug development/ clinical trials: 5 years ()
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