Manager provides ongoing technical and administrative guidance and oversight in support of the NIH funded contract SMILE (Patient Safety Monitoring in International Laboratories) and other sponsor funded projects. Maintains a collaborative and close working relationship with the appointed sponsor contact: The Division of AIDS Contract Office Representative (DAIDS-COR). Responsible for the efficient utilization of assigned resources, planning for future research and development, staffing, equipment and space. Assists with the development and administration of the project budget. Develops, maintains and recommends QA/QC programs to multiple international laboratories, NIH representatives and other study clients or sponsors. In collaboration with the Principal Investigator develops project goals, objectives policies and procedures. Ensures adherence to JHU and Pathology department policies and procedures. Performs other related administrative and professional duties as assigned. International travel is required.
25% Manages the day to day operation of the SMILE Project. Oversees the quality of technical support and monitoring performed by staff in accordance with the direction given by the sponsor for compliance with Good Clinical Laboratory Practice (GCLP). Is knowledgeable of and can advise on recommendations of other regulatory agencies and resources, such as, Clinical Laboratory Improvement Act (CLIA), Food and Drug Administration (FDA), College of American Pathologists (CAP) and Clinical Laboratory Standards Institute (CLSI). Provides guidance and assistance to staff, the project sponsor(s), clinical trials networks and other contractors with resource allocation, operational questions, policy development, technical issues, troubleshooting, and on patient and laboratory safety issues.
35% Participates in the overall vision, specification, design, budget administration and review, implementation and modification of projects related to Johns Hopkins University and contract requirements. Meets financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions. Monitors project produced reports and data to ensure quality and integrity.
25% Manages human resources. Supervises the orientation, training, mentoring and development of project staff. Plans, coordinates staffing patterns to effectively and efficiently support the project. Acts as a resource to staff for resolving difficult issues. Coordinates and facilitates recruiting, selecting, orienting, training, assigning, scheduling, coaching, and counseling employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; enforcing policies and procedures.
10% Coordinates and participates in the design and development of computer assisted work flow automation, functional and operational informatics, transactional and query database design and Information Technology (IT) improvements as required by the contract sponsor, staff allocation and workload increases.
5% Travels to provide assistance with international laboratories, other clients and monitor staff performance. Attends meetings (including national and international), as required. Updates job knowledge by: participating in educational opportunities, reading professional publications, maintaining personal networks, and participating in professional organizations.
Supervision of Others: Supervises project staff including: laboratory professionals (International QA/QC Coordinators), Program Officer and oversight of IT staff projects.
Equipment, Machine, or Tool Requirements: Computer, Scanner, Copier, Telephone, Fax. Experience and understanding in laboratory instrumentation and equipment including: assay methods, maintenance requirements and general operational trouble shooting.
Bachelor of Science degree in Medical Technology, Biology, Chemistry or related field required. Medical Technologist ASCP certification or equivalent technical certification, required. Master’s degree preferred.
Ten years’ experience in a clinical laboratory, of which it is preferred that three years are in a supervisory position; must have experience in Hematology, Chemistry, Immunology and/or Microbiology. Experience as a lead technologist, QC/QA technologist, SMILE or similar clinical trials project staff preferred.
Must be willing and able to travel on international assignments. Experience with international travel and working within different cultural environments preferred.
International travel required, partial telecommute optional.
Must have strong working knowledge of:
The Windows operating system, file organization, manipulations and internet research
Be skilled at business software applications, such as, Adobe products, and the Microsoft Office Suite tools, Word, Excel, and Outlook
Preferred candidates will have:
Knowledge of the Johns Hopkins SAP Financial Enterprise system
Experience in function and design of websites and database
Licensure, Certification, Registration: ASCP certification or equivalent technical certification, required.
Special Knowledge, Skills, or Abilities / Competencies:
Demonstrated leadership and ability to motivate and direct highly qualified technical staff. Extensive technical laboratory experience required. Experience managing projects effectively.
Must have working knowledge of FDA, CAP, CLIA regulations and CLSI procedure formats applicable to an accredited clinical lab.
Excellent written and verbal communication, interpersonal, and training skills. Conflict resolution and team building skills required.
Classified Title: International Lab QA/QC Manager Working Title: International Lab QA/QC Manager Role/Level/Range: ACRP/04/MF Starting Salary Range: $70,805-$97,437 Employee group: Full Time Schedule: M-F 7:00 am - 3:30 pm Exempt Status: Exempt Location: 31-MD:JH at 111 Market Place Department name: 10003048-SOM Pat Clinical Chemistry Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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