Clinical Affairs: Clinical Project Manager
Abbott
**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 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.**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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