- Entry level
- No Education
- Salary to negotiate
- UNITED STATES - ILLINOIS - ABBOTT PARK
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:This position oversees the design,implementation,and monitoring of clinical studies of new and modified in vitro diagnostic products. Ensures that the clinical studies are designed to support product performance claims,validate the products’ intended use and meet regulatory requirements.
Manages and monitors the progress of clinical studies at the site level and ensures that they are conducted,recorded and reported in accordance with the protocol,standard operating procedures (SOP),good clinical practices (GCP) and other applicable regulatory requirements.
Manages study timelines and strategic execution on study deliverables,meet validate user needs and meet regulatory requirements.
Prepares and presents project progress reports to keep management and team informed.
Contributes to and prepares prepare presentations for regulatory meetings,attend regulatory face-face and teleconference meetings and reviews and approves regulatory submissions.
Supervises others in the completion of clinical research related tasks and projects.
Provides support as required in the negotiation of site contracts and budgets and negotiate contracts with services suppliers,laboratories and CROs.
Provide comprehensive management of CROs and other vendors affiliated with the project.
Develops and manages study budgets.
Must remain current with regulations and clinical requirements for diagnostic products and translate the regulatory requirements into clinical study activities,processes and procedures.
Effectively communicate,through the planning and execution of meetings and presentations,project goals,milestones,and updates,to senior management and other functional areas,and regulatory authorities.
Maintains professional,product,and market expertise via independent reading,networking,and training.
Serves as a consultant in broad area of expertise,implements all policies,established procedures,and regulations into daily operations as appropriate.
Interview job candidate sand hires permanent and contract staff.
Manages the orientation and ongoing training for the monitors.
Prepares,contributes to,and conducts direct reports’ performance evaluations.
Identified and implements improvements for increased departmental efficiency.
Manage the implementation of a clinical operations strategy that focuses on productivity,quality and performance of monitors.
May also be responsible for managing of internal monitoring activities,specimen bank activities,specimen procurement,phlebotomy,and design verification studies.
Accountable for achievement of both financial and performance goals for projects and overall area of responsibility.
Responsible for mentoring direct reports and their career development.
Coordinates a broad multi-disciplined work unit.
Responsible,when required,to interact on behalf of a project with FDA reviewers or compliance personnel.
Successful and timely completion of clinical research studies and submissions directly impacts the ability to meet product market entry dates.
Position is accountable for project scope and scheduled completion dates.
Removes barriers impeding the progress of projects and programs.
Recommends actions and develops responses to cope with changing scenarios.
Anticipates future directions and participates in conflict resolution at the management team level.
Bachelor Degree required B.S. in biological science or medical specialty preferred and a Master's Degree or higher is desirable Other: Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) preferred Knowledge of regulations and standards (GCP) affecting IVDs and Biologics required Minimum of 7 years direct clinical research experience of which 3 years functioning in a lead capacity with mentoring, supervisory or demonstrated leadership role. Experience with budgetary responsibility is preferred.
JOB FAMILY:Medical & Scientific Affairs
LOCATION:United States Abbott Park : AP20 Floor-1
TRAVEL:Yes, 20 % of the Time
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Work with human blood or other potentially infectious materials
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
About the company
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on Twitter @AbbottNews and @AbbottGlobal.
We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.