Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
The clinical project manager (CPM) designs, implements, and monitors clinical studies of new and modified in vitro diagnostic products. 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. Manages large projects, complex projects, and/or several smaller projects. Has established a high degree of competence in clinical research and has experience in all aspects of a clinical research program. Functions independently with a significant degree of autonomy. Manages direct reports, provides career development, and conducts performance evaluations. Manages departmental activities including budget and project planning.
Complies with all policies, established procedures, and regulations related to clinical research.
Actively participates as a member of the cross-functional project team.
Participates in assessing performance data generated by R&D/Business Teams prior to initiation of the clinical study.
Acquires a basic understanding of the principles of the assay and/or instrument and “hands-on” knowledge and skills in performing assigned assays or operating instruments.
Prepares design validation plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions.
Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies.
Identifies and qualifies clinical investigators and clinical sites.
Proposes and negotiates budgets for clinical studies.
Initiates payments to clinical sites and manages project budgets.
Obtains and reviews all required essential documents necessary for study initiation.
Works with Statistical Support to develop data and statistical analyses of clinical data.
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.
Conducts pre-study, initiation, interim, and closeout monitoring site visits and completes site visit reports.
Maintains accurate and timely sponsor/site correspondence and communication.
Reviews data, prepares, and presents clinical data reviews and data summaries.
Responds to audits and data queries.
Prepares and presents project progress reports to keep management and team informed.
Prepares the clinical sections of regulatory submissions and international registration packages.
Prepares and reviews product labeling and promotional materials.
Assists Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study.
Participates in presentation of clinical information to the FDA.
Initiates publication or presentation of clinical data in professional journals or meetings.
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.
Advises and trains newly hired CRAs and Sr CRAs with departmental procedures.
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.
Assumes responsibilities of the department manager in their absence.
May perform other duties as assigned.