Clinical Affairs: Clinical Project Manager

<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>JOB DESCRIPTION:</b></h2><h3><br /><b>Working at Abbott </b></h3><h3>At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:</h3><ul><li><h3>Career development with an international company where you can grow the career you dream of.</h3></li><li><h3>A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.</h3></li><li><h3>A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.</h3></li></ul><h3></h3><h3><b>Primary Function</b></h3><h3>Provides project management and leadership to plan, prepare and execute high quality large scale and/or complex clinical program(s). Leads the clinical project team members toward completion of deliverables in a timely fashion within an agreed project timeline.  Internally interfaces with data management, biostatistics, clinical research associates, business leads, medical directors, functional management, and acts as a company liaison with site investigators and clinical site staff.</h3><h3></h3><h3><b>Key Responsibilities</b></h3><ul><li><h3>Responsible and accountable for several (possible global) clinical trials.</h3></li><li><h3>Responsible for ensuring the trial is “audit ready” at all times (project team training records, central files, system validation, etc.).</h3></li><li><h3>Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.</h3></li><li><h3>Responsible for effective communication within the Clinical Project Team and with functional management.</h3></li><li><h3>Provides regularly updates regarding the status and progress of the trials</h3></li><li><h3>Manages the program(s) within the approved budgets and timelines.</h3></li><li><h3>Responsible for writing of clinical project deliverables such as protocols, final study report, study manuals, study tools, etc.</h3></li><li><h3>Directs forecasting of devices necessary for project in collaboration with supply-chain.</h3></li><li><h3>Supports the coordination and attends investigator and coordinator meetings, representing the clinical project team.</h3></li><li><h3>Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.</h3></li><li><h3>Responsible for the identification of project risks and the development and implementation of the mitigations for these risks.</h3></li><li><h3>Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits.</h3></li><li><h3>Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable company’s SOPs and policies.</h3></li></ul><h3></h3><h3><b>Requirements</b></h3><h3></h3><h3><b>Minimum Education &amp; Experience:</b></h3><ul><li><h3>Bachelor’s-level degree required.  Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. </h3></li><li><h3>Masters-level degree (or equivalent), or qualification in clinical trial management / medicine preferred. </h3></li><li><h3>8&#43; years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 3&#43; years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. </h3></li><li><h3>Previous experience with complex, global trials is preferred.</h3></li></ul><h3><b>Working Conditions:</b></h3><ul><li><h3>General office environment, approximately 30 - 50% travel to research laboratory or hospital settings, meetings and other Abbott facilities.</h3></li><li><h3>Potential exposure to blood borne pathogens and other potentially infectious materials</h3></li></ul><h3><b>Competency Expectations:</b></h3><ul><li><h3>Ability to understand strategic goals and match the business needs of the company. </h3></li><li><h3>Ability to develop good interpersonal relationships with clinical / medical professionals. </h3></li><li><h3>Good verbal and written communication and presentation skills. </h3></li><li><h3>Must be familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies. </h3></li><li><h3>Ability to independently manage and provide significant tactical and leadership guidance to clinical team. </h3></li><li><h3>Independently motivated. </h3></li><li><h3>Demonstrated previous success managing multiple, complex, and international projects.</h3></li></ul><p></p><p></p><p></p><p></p><p></p><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p><b>The base pay for this position is </b></p>N/A<p style="text-align:left"><span>In specific locations, the pay range may vary from the range posted.</span></p><p style="text-align:inherit">     </p><h2><b>JOB FAMILY:</b></h2>Research and Discovery<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>DIVISION:</b></h2>MD Medical Devices<p style="text-align:inherit">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</p><h2><b>LOCATION:</b></h2>Japan &gt; Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>ADDITIONAL LOCATIONS:</b></h2><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>WORK SHIFT:</b></h2>Standard<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>TRAVEL:</b></h2>Not specified<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>MEDICAL SURVEILLANCE:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>SIGNIFICANT WORK ACTIVITIES:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p style="text-align:inherit">     </p><p style="text-align:inherit">     </p>