Sr Manager, Clinical Affairs (#11-68209) AccessClosure

SUMMARY/RESPONSIBILITIES:

SUMMARY:

Responsible for development of the company?s clinical strategy, and for determining the studies essential for exploring the safety and efficacy of ACI?s products through collaboration with cross functional groups within ACI. This position will chart and execute the course for the company?s clinical strategy in full partnership with senior members of the sales, marketing and R&D organizations to ensure the strategy supports and advances the company?s growing commercialization efforts.



ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

Define company?s U.S. and OUS clinical strategies with an eye toward both IDE studies that advance regulatory goals in expanding product labeling, and also post-market studies that support commercial initiatives
Responsible for the implementation of clinical trials, from drafting protocols to interpreting the results and working with investigators to author scientific publications and presentations at medical meetings
Engagement in all aspects of a clinical trial including activities involved in the pre and post market environment.
Play a key role in helping cultivate relationships with important physicians both regionally and nationally
Leadership in medical advisory meetings, national and regional sales meetings, and publication strategy and execution.
Establish processes and procedures to standardize appropriate protocol preparation, study design analysis, amendments, IRB submissions, etc.
Design clinical trial protocols and, partnering with sales and marketing, shepherd the process of investigative site selection
Manage IRB process and site initiations at all sites involved in AccessClosure studies
Develop all study materials such as case report forms, informed consent, site contracts, protocol review cards, etc.
Identify and select in-house or out-sourced data management and biostatistical solutions
Ensure study timelines are met, with regular progress reports provided
Manage clinical staff to ensure timely site payments, proper site monitoring, data entry and adequate device availability and shipping
Oversee clinical trial budget and establish budget tracking system
Coordinate preparation of clinical sections of regulatory submissions
Serve as a resource on clinical issues related to complaint handling, and MDR processing and analysis
Respond to clinical questions from customers, regulatory bodies and the sales force
Play an active role in providing clinical education during sales training to ensure AccessClosure representatives exceed customer expectations of their clinical knowledge.



EDUCATION/EXPERIENCE:

Bachelor of Science degree or equivalent and a minimum 7 years experience in medical device or biopharmaceutical fields with knowledge of FDA requirements and good clinical practices, including a minimum of 2 years of people management responsibilities
Healthcare background, preferably in cardiology with patient care experience
Excellent understanding of GCPs and CFRs
Clear and effective communication skills
Proficiency in MS Word and Excel required
High attention to detail and accuracy is required
Ability to perform multiple tasks concurrently with accuracy
Experience with data bases, data analysis, statistics
Demonstrated expertise in executing clinical trials, including effective management of projects and timelines, and interpretation/evaluation of clinical data.
Demonstrated leadership experience, including excellent analytical, planning and communication skills in a dynamic, fast-paced environment. This individual must have a clear track record of bringing passion, urgency and a results-driven orientation to a team.
Understands the cardiovascular environment and very preferably, brings significant experience from this field.
Desire to partner closely and effectively with a very high-caliber sales and marketing organization.
Influential communicator with strong presentation skills, and one who projects a clear, authoritative presence with physicians, sales representatives, the executive team and others.
Open to frequent travel in support of clinical trial execution and clinically-related commercial efforts



SUPERVISORY RESPONSIBILITIES:

Will supervise Clinical department



WORK ENVIRONMENT:

Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials.
Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
Work includes potential exposure to chemicals.

Location:	645 Clyde Avenue Mountain View, CA 94043 United States