Position Summary:
Are you an experienced Laboratory Professional who is eager to make an impact on global health at an innovative and mission driven organization? Learn more here!
IAVI is seeking a dynamic and experienced Manager, Clinical Laboratory Operations to lead lab operations for IAVI-sponsored clinical trials. The Manager coordinates central lab activities, liaises with clinical research sites, clinical teams, and vendors ensuring lab operations are executed effectively. The Manager improves and develops SOPs, prepares the lab for trial operations, and oversees central lab operations. The Manager is knowledgeable and versed in relevant regulations and ensures quality and compliance of lab operations.
Key Responsibilities:
Laboratory operations:
Coordinate and manage clinical research site (“site”) and central lab related activities, including regular meetings, managing timelines and deliverables, lab budget management, coordinating activities and deliverables with other lab leads for IAVI conducted clinical trials.
Serve as main point of contact for lab operations for sites, lab vendors and the Clinical Trial Team.
Support site lab feasibility assessment and conduct site laboratory qualification visits, follow-up, and review site laboratory SOPs.
Contribute to development of lab related information in protocol, ICF, CRF and study operations manuals.
Develop laboratory operations manual (including specimen management plan) and update as needed throughout the clinical trial and specimen shipment plan.
Assist in development of diagnostic algorithms for laboratory endpoints in clinical trials (e.g. TB, HIV).
Develop protocol specific tools for the management of research samples, e.g. sample collection tables, Laboratory Requisition forms, data/sample flow maps.
Prepare site laboratories for enrollment, including support with procurement of reagents, assay development and testing (if required) and coordinate provision and distribution of central lab supplies and materials.
Assist in the identification, evaluation, and selection of central laboratories, including review of vendor SOPs, operational strategies, budgets, and support budgeting and contracting activities.
Develop and implement laboratory quality oversight plan.
Develop and conduct training for site lab operations during Site Initiation Visit
Proactively identify and resolve issues/risks with sites and central lab operations that arise and implement corrective and preventive measures as required.
Oversee site sample storage e.g. review of temperature reports management of excursions and oversight of sample management in the Laboratory Information Systems.
Review site lab equipment maintenance logs and service records during Lab oversight visits.
Monitor internal quality control procedures, including monitoring and reporting of contamination rates and cross contamination rates at site labs and /or central laboratories, as applicable.
Conduct lab quality oversight visits at site labs to ensure compliance with protocol and relevant lab standards.
Coordinate and oversee internal / external audits of site labs and central labs and coordinate and review CAPAs.
Ensure lab related essential documents are filed in the TMF throughout the study conduct.
Coordinate data transfers from laboratories to clinical database, including execution of data transfer agreements.
Coordinate sample shipments and documentation, including material transfer agreements, export permits , import permits for lab samples and reagents.
Support data cleaning activities of lab data, in consultation with Data Management.
Coordinate sample destruction / storage and documentation at the end of the study.
Perform any other duties as assigned by the Line Manager.
Departmental and knowledge development activities:
Remain up to date on knowledge of GCP, GCLP and other relevant regulations.
Remain abreast of scientific knowledge, EQA programs and TB, HIV and Emerging Infectious Disease (EID) diagnostic technologies, trends, and activities.
Participate in training activities for new staff, as needed.
Education and Work Experience:
Education requirement (e.g. Bachelor’s in life sciences, public health, or related field is required; An advanced degree is highly preferred;
A minimum of 5 years’ work experience in academic, nonprofit organization, and/or research environment is required.
Experience with research capacity strengthening is highly preferred.
Experience with research endpoint assays is preferred. (e.g. PBMCs, Elispots, etc.)
Scientific & Technical training; laboratory qualification in Clinical Pathology preferred; Other professional qualifications from state registered bodies and /or experience working in accredited laboratories also considered.
Qualifications and Skills:
Ability to conduct presentations of technical information is required.
High level of interpersonal skills and the ability to work effectively in a cooperative and collaborative manner with all levels, across functional teams both internally and externally is required.
Ability to work on problems of moderate complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is required.
Excellent project planning and implementation skills in a cross-disciplinary and multi-cultural team are required.
Excellent knowledge of ICH GCP, FDA CFR guidelines, GCLP, and relevant country specific regulations related to laboratory operations are required.
Excellent verbal and written communication skills are required.
Flexibility to change priorities and be comfortable with changing deadlines to meet organizational needs is required.
Excellent computer skills and proficiency in Microsoft Word and Excel is required.
Ability to travel up to 50% of the time is required
Extensive hands-on experience in TB diagnostic laboratories is required
Knowledge of TB. HIV and EID diagnostic testing algorithms is required
High level of independence in performing responsibilities is highly desirable.
Strong Clinical Trials background is highly desirable.
Apply via :
recruiting.ultipro.com
