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Clinical Research Project Manager

The Clinical Research Project Manager is responsible for managing the activities of the Clinical Research group, including: development of clinical study and publication strategy; leading design of clinical studies for the generation of impactful clinical data in support of the company's key initiatives; and dissemination of the results in multiple forms (ex. peer-reviewed publications).  The Clinical Research department also provides the Clinical perspective when interfacing with multiple departments including Regulatory, Product Development, R&D, and Marketing. Skills Requirements Basic knowledge of statistics/biostatistics Ability to balance multiple ongoing projects, timelines, and outputs Ability to work with guidance from upper management to lead the Clinical Research group projects while also independently performing job functions Ability to effectively communicate information to internal customers, management, and external customers (surgeons, academic consultants, regulatory agencies, etc.) Computer skills, including Microsoft Office Suite and Microsoft Outlook Technical and medical writing skills Excellent written and verbal communication skills Principal Responsibilities Lead the project activities of the Clinical Research department and ensure the meeting of critical deadlines/milestones Development of clinical study and publication strategies Create study plan overviews and initial budgets to obtain executive approval Lead the design of clinical study protocols in conjunction with the other functional areas of the Clinical Research group to provide meaningful clinical data to fulfill the needs of the business (regulatory requirements, marketing claims, etc.) Analyze, interpret, and disseminate results from clinical studies Identify existing clinical data and facilitate the publication of that data to support the company's key initiatives Provide clinical input for various groups including Regulatory (PMCF study plans, responding to questions), Product Development/R&D (IOVV, DFMEA), Marketing (information for NBCs, development of materials and sales tools) Support other functional areas of the Clinical Research group during the execution of assigned clinical studies Manage the submission/approval process for the Investigator Initiated Study program Provide post-market research input and support the writing of the clinical evaluationreports  Accountability A person in this position has the responsibility for adhering to schedules set forth by management. This role will oversee the expense budget and will have the responsibility to report any potential budget overruns to the manager. EXPERIENCE & EDUCATION REQUIREMENTS 6 yr Min in clinical or scientific field with BS degree in science or engineering 3-5 yr Min in clinical or scientific field with MSdegree in science or engineering 2-4 yr Min in clinical or scientific field with PhD degree in science or engineering Documented evidence of technical writing skills and previous peer-reviewed publication experience Previous experience with experimental/study design (Is not limited to clinical trials, and can include basic science and animal studies) Previous personnel management experiencepreferred, but not required CLINI01449
Salary Range: NA
Minimum Qualification
5 - 7 years

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