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Project Manager, Mycobacteriology

Job Description:
Responsibilities The Project Manager (PM) for Mycobacteriology Research functions as a collaborator for HIV and TB research in support of clinical studies sponsored by the Division of AIDS (DAIDS) / National Institute of Allergy and Infectious Disease (NIAID) / National Institutes of Health (NIH).
The employee will play an integral role in the implementation of mycobacteriology/TB-centric clinical trials protocols, information management and Network organization and structure.
The PM is responsible for reviewing and implementing protocol testing, reviewing laboratory quality assurance information, working with laboratories to resolve audit/monitoring visit findings and supporting capabilities required to conduct clinical trials as required by the protocol Sponsor.
The PM contributes to scientific technical aspects of clinical research laboratory capacity building, particularly in the area of mycobacteriology studies.
The PM also provides committee coordination and administrative support to laboratory related committees and working groups.
Qualifications Required: Must possess at least a Bachelor's (BS) degree in a science field or formal training as a Medical Technologist.
Have at least five (5) years of experience working in a Mycobacteriology laboratory setting.
Must work well as part of a team and individually under very limited (moderate/direct) supervision; exhibit a high degree of initiative, flexibility, organization, attention to detail, problem-solving and time management; and effectively manage a heavy workload with multiple projects and competing priorities.
Knowledge Technical: Familiarity with both classic and molecular TB screening and diagnostic and drug susceptibility testing methods, including laboratory QA/QC processes.
Have a working knowledge of recent CDC and WHO guideline for laboratory testing and diagnosis of TB disease.
Knowledge or experience with other infectious diseases such as HIV/AIDS, preferred.
Familiar with laboratory methods, and technologies used to screen and diagnose LTBI, TB and MDR/XDR-TB.
The PM must have a thorough understanding of Good Laboratory Practices and/or CLIA/CAP requirements.
Laboratory Testing and Analysis: The PM should be able to: recognize deviations from expected and/or normal results; analyze results for possible solutions; recommend new test methodologies and/or modify existing ones to achieve desired results; evaluate new laboratory techniques; prepare and analyze a variety of data; provide detailed documentation and analysis of clinical research data.
Laboratory Operations: The PM should be able to: organize and direct the daily activities of participating laboratories; participate with supervisor in work planning, staff training, evaluating work, and counseling; evaluate quality control procedures; review work of others for conformance with quality control procedures; maintain quality control records; perform safety checks; ensure compliance with health and safety guidelines.
Instruction: Ability to develop and provide instruction and training for staff at international laboratories in performance of laboratory procedures including total quality management.
Ability to develop necessary training tools to assist laboratories (i.
e.
, checklists, training materials, etc.
).
Working knowledge of assay validation, quality assurance and quality control procedures and properly documenting laboratory processes and procedures as well as corrective actions and preventative actions (CAPA).
Excellent interpersonal and client management skills with a professional and customer service oriented demeanor.
Excellent verbal and written communication skills, which may include business and technical writing, editing and proofreading.
Experience working with laboratory data/information management systems or laboratory database.
Excellent verbal and written communication skills, which may include business and technical writing, editing and proofreading.
Excellent interpersonal and client management skills with a professional and customer service oriented demeanor.
Preferred: Master's level degree or higher.
Laboratory management experience.


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