Manages all aspects of an assigned clinical program or programs (globally) to ensure that all studies within the program are completed on time within budget and in compliance with SOPs, Regulatory regulations and ICH/GCP guideline and in alignment with Therapeutic Area (TA) strategies and goals. Typically works on large, complex programs (i.e., global, registrational programs) with a large number of sites and a significant number of patients. Working with the MD and/or the Clinical Scientist, provides input to the clinical development plan (CDP). Uses in-depth knowledge of therapeutic area, TA strategies and operational expertise to oversee the CDT, implementation of the CDP, and the development of clinical trial protocol concept in collaboration with the Clinical Development Team. Takes a broad, strategic leadership role in ensuring the successful development and execution of the Clinical Development Plans; utilizes operational expertise, knowledge of TA strategy and TA scientific input when planning program feasibility, developing strategies for country selections, CRO/ vendors use and evaluations and planning for contingencies. Participates in business development evaluations from the clinical research and operational perspective.
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