|GTC Biotherapeutics Inc., a biotechnology company with headquarters in Framingham, MA, is the industry leader in the production of therapeutic proteins in the milk of transgenic animals. GTC is hiring a Clinical Project Manager who will lead the forecasting, planning, implementation and execution of clinical trials in alignment with the company's strategic objectives, timelines and budget, as well as in accordance with ICH/GCP guidelines and country regulations. Reporting to the Director of Clinical Development, the Clinical Project Manager will be responsible for effective global management of both internal and external relationships along with maintaining strong partnerships with investigators, CROs, central labs, and other vendors.
A thorough understanding of FDA, ICH, and GCP guidelines as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
Excellent interpersonal and negotiation skills
Strong verbal and written communications and presentation skills
Strong leadership, planning and project management skills
BA/BS/RN with 5+ years of progressive clinical project management experience in designing, executing, analyzing and presenting results of clinical trials.
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