Clinical Affairs: Clinical Project Manager

JOB DESCRIPTION:

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.

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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.

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Primary Function

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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.

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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.

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Requirements

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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.

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:
No

## MEDICAL SURVEILLANCE:
Not Applicable

## SIGNIFICANT WORK ACTIVITIES:
Not Applicable