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Clinical Affairs Manager Ekos
THIS JOB HAS EXPIRED
SUPERVISOR: Vice President of Clinical & Regulatory AffairsMAIN PURPOSE OF JOB
Responsible for overseeing all clinical activities related to one or more clinical studies and performing/managing the daily operations associated with the studies. This position should be able to independently handle various clinical study assignments. The primary objective of the Clinical Affairs Program Manager is to conceptualize, plan, design, execute and monitor clinical studies. This includes overall project management of multiple clinical studies or Contract Research Organizations (CROs) and project planning to include assessment of development team head count, resource planning, project timelines and effective utilization of budget. This person will manage Clinical Research Associates (CRAs) and consultants, including their development, coaching and mentoring. This person will be able to effectively communicate project-related information, including the planning and execution of meetings and presentations. Priorities must be continually evaluated and monitored for progress. Monthly management reports and project updates are required to be submitted to VP of Clinical & Regulatory Affairs.
MAIN JOB DUTIES/RESPONSIBILITIES
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Manage department to efficiently utilize manpower and financial resources.
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Responsible for creating clinical strategy, planning and management of all EKOS clinical studies including related management of contracted organizations conducting studies in foreign countries.
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In collaboration with the VP Finance & Administration, negotiate and administer all activities with Contract Research Organizations concerning contracts and activities including adherence to SOPS, protocols, and medical evaluation according to parameters of each trial
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Manage together with outside legal counsel the completion all clinical aspects of PMA, IND, and/or 510K regulatory applications coupled with international regulatory submissions to appropriate agencies inclusive of CE mark application. Participate in clinical development activities and strategies.
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Manage and assist in the development of clinical trial designs with Clinical Research Organizations. Monitor and analyze clinical trial data and direct the disposition of results.
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Perform site initiations, monitoring visits, close out visits as required.
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Responsible for device clinical trial activities and reporting of any and all clinical data in regards to regulatory compliance.
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Monitor and analyze clinical study data and direct the disposition of results.
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Establish and maintain relationships with key physician champions to facilitate execution of studies.
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Work with physicians on an individual and group level to develop and execute clinical studies that meet company Marketing, Regulatory and R&D requirements.
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Provide visibility to Sales organization on status of clinical sites and principle investigators
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Coordinate publication strategy of clinical results with Marketing department.
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Responsible for completion, compliance and assessment of safety / efficacy reports as required by the Food and Drug Administration and international regulatory bodies, clinical development plans, and research strategies.
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Responsible for providing assistance in direction of overall corporate strategy including, but not limited to formalizing corporate planning and evaluating market potential.
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Manage, train, and monitor Clinical Research Associates in the production and administration of clinical study protocols.
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Responsible for any function not specifically assigned that leads to the success and growth of EKOS.
Clinical Affairs Manager Job Description REV C? 7.3.12
Clinical Affairs Manager Job Description REV C? 7.3.12
QUALIFICATIONS
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An advanced scientific or medical degree is preferred.
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10 years experience in a research and development or regulatory environment with expertise in managing device regulatory programs is essential.
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This individual must have interacted with top executives.
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A working knowledge of GMP, ISO 13485 and MDD requirements.
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Knowledge of international regulatory agencies and submission processes is required.
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Proven ability to work independently and external to the company for the majority of the time.
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Ability to travel (minimum of 50%) will be an essential part of this position.
| Location: | 11911 North Creek Parkway South Bothell, WA 98011 United States |
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THIS JOB HAS EXPIRED
Ekos
Investors: ARCH Venture Partners, Ascension Health Ventures, Bessemer Venture Partners, NGN Capital, Prism VentureWorks, Technology Partners, WRF CapitalAll Jobs: at Ekos
| Web Site: | www.ekoscorp.com |
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| Headquarters: | 11911 North Creek Parkway South Bothell, WA 98011 United States |
| Industry: | Medical Devices and Equipment |
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