- Entry level
- No Education
- Salary to negotiate
- Lake Forest
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 conduct of clinical studies for U.S. and non-U.S. regulatory submissions and studies under Design Control. Establishes long range plans and goals and is responsible for the implementation and maintenance of the clinical research-related policies,processes and procedures related to the Design Control subsystem of the Division Quality system. This position is also responsible for management of clinical research training and development. This position will work closely with the product development teams within a business organization and also interface with senior management and other functional areas within the business organization to support clinical research strategic objectives. This position provides strategic clinical direction and consultation for Clinical Research including new product development and interactions with Regulatory Agencies. Positions requires knowledge of the regulations and standards affecting IVDs and Biologics as well as an understanding of the clinical utility of the products under evaluation.
Responsibilities include: - Prepare budgets and manage the clinical operations program within established budget and timelines by ensuring development of accurate study budgets,contract development and execution,and approving payments and tracking of study expenditure.
Direct the design,planning,development and monitoring of all clinical studies to ensure fulfillment of requirements for regulatory submissions.
Coordinate functional areas involved in clinical operations to solve problems,assure project progress and timely completion of project goals.
Direct Clinical Research Managers to ensure that clinical studies that meet user needs and regulatory requirements are conducted.
Manage clinical operations by developing,mentoring,and effectively delegating.
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.
Develop and implement training programs to ensure compliance with relevant FDA and international regulations and ensure adherence to ICH/GCP guidelines.
Monitor training effectiveness by assessing trends in audit observations and drive continuous improvement initiatives by developing new training activities,as appropriate.
Negotiate contracts with investigators,vendors,and CROs.
Provide compliance guidance on the conduct of clinical research division-wide,for developing and overseeing a quality training program and for compliance in all audits of the Clinical Research organization.
Represent the Division's clinical research programs at cross-functional meetings,FDA meetings,FDA Advisory Committee meetings and in discussions with senior management and trade meetings.
Job responsibilities are performed for the development and registration of in vitro diagnostic products,including those classified as biologics,with adherence to SOPs,regulatory requirements,and project timelines.
Primary accountability and areas of impact include the following: - Accountable for achievement of performance and financial goals for area of responsibility.
Aligns goals with long-term business needs of the organization.
Uses resources effectively ,reviews and monitors budget. - Responsible for making timely decisions that reflect a consideration of the facts and data at hand and are in alignment with the overall business organization’s goals. - Responsible for building relationships throughout the business organization and motivating the Clinical Research team.
Must be skilled in relationship building and matrix management,demonstrating superior leadership and coaching skills. - Effectively writes,presents and communicates information to internal and external clients,including business organization management. - Must have effective negotiation skills.
Accountable for interactions with FDA or other regulatory agencies regarding clinical research issues. - Responsible for continuous improvement initiatives,leveraging new technology consistent with regulatory and compliance strategies,and assuring appropriate training and education programs are in place.
Tracks appropriate metrics to ensure the effectivity of these programs. - Maintains,promotes,and models ethical and organizational principles by adherence to the Abbott Code of Business Conduct.
Bachelor Degree required. B.S. in biological or medical science preferred. Master's Degree or higher is desirable. Preferred: Clinical Laborator
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.