Clinical Affairs Clinical Project Manager

JOB DESCRIPTION:

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 companys SOPs and policies.

Requirements

Minimum Education & Experience:

• Bachelors-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

In specific locations the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: