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Senior Clinical Scientist

Company: iRhythm Technologies
Location: San Francisco
Posted on: October 19, 2020

Job Description:

The Senior Clinical Project Manager/Clinical Scientist is responsible for the management of all aspects of clinical research for assigned project(s). The CPM/CS, in concert with the clinical director, is accountable for achieving successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints. Essential Duties and Responsibilities include: Proactively manage project level scientific and operational aspects of clinical research projects and clinical trials including management of trial timeline, budget, and resources. Lead development of all clinical study documents from trial design to protocol development including endpoint selection. Provide efficient updates on trial progress, with respect to project plan, contracts, trial budget and timeline management, quality standards and risk mitigation. Lead study startup process, including but not limited to conduct of the trial kick-off meeting and training, the set-up of trial materials, and finalization of clinical trial agreements and budgets. Ensure effective project plans are in place and operational for each trial and work proactively to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), guidelines and regulatory requirements. Ensure potential study risks are escalated to the attention of the senior management when appropriate. About you: Advanced Degree in Life Sciences required (MD, PhD preferred) Ten or more years of clinical science and clinical operations experience Five or more years of clinical project management experience at a sponsor or CRO company is preferred People management experience Therapeutic experience in cardiology or cardiovascular field Read, write and speak fluent English; excellent verbal and written communication skills Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and guidelines Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 30 % of work time.

Keywords: iRhythm Technologies, San Francisco , Senior Clinical Scientist, Healthcare , San Francisco, California

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