JOB DESCRIPTION:
General Summary:
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 the 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.
Duties and Responsibilities:
- Responsible and accountable for several (possibly 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 the attainment of project deliverables.
- Responsible for effective communication within the Clinical Project Team and with functional management.
- Provides regular updates regarding the status and progress of the trials
- Manages the program(s) within the approved budgets and timelines.
- Responsible for the writing clinical project deliverables such as protocols, final study reports, 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 the 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.
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 bloodborne 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 guidelines governing the conduct of clinical studies. Ability to independently manage and provide significant tactical and leadership guidance to the clinical team. Independently motivated. Demonstrated previous success in managing multiple, complex, and international projects.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Research and Discovery
DIVISION:MD Medical Devices
LOCATION:Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable
