Clinical Affairs Clinical Project Manager
Job Summary
- 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.
- 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.
- 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.
- 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
- 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/AIn specific locations the pay range may vary from the range posted.
Required Experience:
IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more