Clinical Affairs: Clinical Project Manager

Location: Japan - Tokyo

Category: Research & Development

Employment Type: Full time

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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.

Major 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.