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. Please note that candidates need to be eligible to workin the U.S. without Abbott sponsorship.
This position has full authority and responsibility to carry out job duties as a Clinical Research Director. This position develops, implements and trains all Clinical Research personnel in procedures and tools for conducting clinical research globally. Has responsibility for staying current with regulations and training Clinical Research staff accordingly. Ensures that the clinical studies are conducted per established policies, procedures, regulations, and Good Clinical Practice (GCP). Participates in the preparation of regulatory submissions and international registration packages. Has established a high degree of competence in clinical research and has experience in all aspects of a clinical research program. Manages direct reports, provides career development, and conducts performance evaluations. Manages departmental activities including budget and project planning. This position will work closely with Quality Assurance to ensure department compliance with all Abbott/AMD policies and will be the lead representative for all internal and external agency audits
Responsible for compliance with applicable Corporate and Divisional policies and procedures.
Responsible for establishing global clinical policies, processes and procedures for the AMD clinical organization.
This includes responsibly for Abbott SOPs which comply with Global Practices (GCPs) and Abbott Corporate and Divisional Polices.
Ensures that AMD clinical practices are within regulatory, Abbott and ethical compliance.
Responsible for the creation, maintenance, implementation and effectiveness of the global clinical SOPs and clinical trial management tools.
Partners with other department personnel to assess/allocate resource and budget.
Routinely assess department compliance status and coordinate/conduct Clinical Process Compliance Update meetings with AMD Clinical Project managers.
Responsible for long-range resource planning and budgeting in support of current and future objectives and strategies.
Maintain currency in regulations, Abbott policies, and emerging new regulations affecting clinical research to ensure AMD Clinical systems, processes, procedures and training appropriately reflect current global standards.
Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines, assures subject rights, safety, and welfare are protected, ensures data integrity through completeness, accuracy, and legibility.
Partners with Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study.
Participates in presentation of clinical information to the FDA.
Maintains professional, product, and market expertise via independent reading, networking, and training.
Functions independently in the field and interacts with all levels of medical and scientific professionals.
Serves as a consultant in areas of expertise.
Participates in interviewing and hiring job candidates.
Directs others in the completion of tasks and projects.
Suggests improvements for increased departmental efficiency.
Develops management and supervisory skills necessary for advancement.
Prepares, contributes to, and conducts direct reports’ performance evaluations.
May perform other duties as assigned.
Collaborates with Quality Assurance and other departments to ensure Clinical Research department compliance with Abbott corporate and divisional polices.
Effectively execute training programs for all Clinical Research personnel globally.
Participates in the preparation and management of annual budgets for the Clinical Research department Interacts with FDA and other worldwide regulatory agencies to support compliance audits.
B.A. or B.S. in the biological sciences or equivalent job related experience of at least 10 years. Advance degree (MS, PhD) is preferred Other: Medical Technology MT(ASCP) or equivalent, or certification as a clinical research associate (CCRA) is desirable This position requires directly related experience in Clinical Research planning and execution, including an understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and the scientific, statistical, regulatory and compliance requirements of clinical research. Minimum of 10 years relevant professional experience including: Clinical Research 3 to 5 years and Supervisory or management experience 3 to 5 years and Laboratory (hospital, research, industrial) 3 to 5 years or Quality Assurance/Auditing 1 to 2 years or Diagnostic Customer Contact 1 to 2 years Other: This position requires previous experience managing large or complex clinical studies; the ability to achieve goals through interaction with individuals not under their direct control; excellent oral and written communication skills, familiarity with desktop computer office software, ability to travel (20-35% US and/or international), and participation in professional activities outside of normal business hours