Tokyo, JPN
36 days ago
Clinical Affairs: Clinical Project Manager
**Working at Abbott** **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:** **Career development with an international company where you can grow the career you dream of.** **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.** **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.** **Primary Function** **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.** **Key Responsibilities** **Responsible and accountable for several (possible global) clinical trials.** **Responsible for ensuring the trial is “audit ready” at all times (project team training records, central files, system validation, etc.).** **Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.** **Responsible for effective communication within the Clinical Project Team and with functional management.** **Provides regularly updates regarding the status and progress of the trials** **Manages the program(s) within the approved budgets and timelines.** **Responsible for writing of clinical project deliverables such as protocols, final study report, study manuals, study tools, etc.** **Directs forecasting of devices necessary for project in collaboration with supply-chain.** **Supports the coordination and attends investigator and coordinator meetings, representing the clinical project team.** **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.** **Responsible for the identification of project risks and the development and implementation of the mitigations for these risks.** **Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits.** **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.** **Requirements** **Minimum Education & Experience:** **Bachelor’s-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred.** **Masters-level degree (or equivalent), or qualification in clinical trial management / medicine preferred.** **8+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 3+ years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.** **Previous experience with complex, global trials is preferred.** **Working Conditions:** **General office environment, approximately 30 - 50% travel to research laboratory or hospital settings, meetings and other Abbott facilities.** **Potential exposure to blood borne pathogens and other potentially infectious materials** **Competency Expectations:** **Ability to understand strategic goals and match the business needs of the company.** **Ability to develop good interpersonal relationships with clinical / medical professionals.** **Good verbal and written communication and presentation skills.** **Must be familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies.** **Ability to independently manage and provide significant tactical and leadership guidance to clinical team.** **Independently motivated.** **Demonstrated previous success managing multiple, complex, and international projects.** An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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