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Clinical Project Manager at Abbott Molecular in Des Plaines, IL
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 researchand 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
Responsible for implementing and maintaining the effectiveness of the quality system.
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.
Supervisory / Management Responsibilities :
Direct and indirect reports may vary with the project and the assignment. Direct reports may also include contract labor.
B.A. or B.S. in the biological sciences
Masters degree is desired
Other: Medical Technology MT(ASCP) or equivalent, or certification as a clinical research associate (CCRA) is desirable
This position requires 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 7-8 years relevant professional experience including:
Clinical Research 3 to 5 years
Supervisory or management experience 2 to 4 years
Laboratory (hospital, research, industrial) 3 to 5 years
Quality Assurance/Auditing 1 to 2 years
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
Accountability / Scope:
Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates. Early identification of unsatisfactory results, operations, or specific problems allows immediate action to be taken by appropriate groups. Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project. Accountable for project scope and scheduled completion date. Works under the direction of the Clinical Research Manager. Responsible for managing direct reports and their career development.