Acts as the microbiology lead for all protocols, including contributing to the development and implementation of project strategy.
Plans, organizes, communicates, and implements domestic and global trials.
Performs qualification visits for microbiology laboratories to determine readiness for performing clinical trials; identify shortfalls and create action plans to prepare laboratories for clinical trial work.
Designs standardized laboratory manuals and standard operating procedures for each clinical trial to ensure comparability for efficacy analyses
Supervises a team of in-house and local Microbiology Consultants (contract staff) in their conduct of day-to-day operations of clinical trials.
Reviews and approves selection of appropriate personnel to perform consultant duties
Trains and orients new team members on corporate culture, corporate expectations and departmental/organizational policies and procedures.
Review/approval of reports from microbiology consultants (local consultants assigned to each lab)
Management of sites; creating and maintaining study related tracking (enrollment, monitoring, regulatory documents, etc.); review of clinical site monitoring reports;
Review of site generated data for accuracy and consistency
Advisor to CRAs to identify problems and propose solutions to maintain projects within designated timelines and budgets.
Plans risk mitigation strategies for the microbiology laboratories and implements solutions to maintain projects within designated timelines and budgets
Oversees vendor management for central and local laboratories, couriers, graphic designers, study-required training, and proficiency testing.
Reviews and oversees budgets at local laboratories and with central vendors.
Supervises reviews of tables and listings and regular microbiology data reviews to ensure data integrity and review trending & consistency across sites.
Prepares and reviews microbiology sections for protocol development, clinical study reports, publications, and regulatory submission documents.
Supports TB program inspection readiness strategies.
Leads the organization, preparation, presentation, issue identification, and follow-up for all portions of investigator and global team meetings related to microbiology.
Coordinates microbiology training programs for directors, CRAs, lab consultants and investigator meetings.
Ensures effective communication and interaction on project-related activities.
Participates in marketing and publication strategies and development.
Provides ongoing analysis, interpretation, and presentation of data.
Attends team meetings as needed
Other duties as assigned
Minimum degree - Bachelors
Knowledge, Skills, and Competencies Knowledge Working knowledge of and experience with tuberculosis (TB).
Working knowledge of and experience with mycobacteriology laboratory techniques and procedures, as well as TB diagnostic technology.
Comprehensive knowledge and experience in clinical development, clinical trial management, and applicable global regulatory requirements and compliance.
Working knowledge of associated disciplines including biostatistics, data management, and medical writing.
Demonstrated skill in designing and managing global clinical trials.
Excellent oral and written communication skills, organizational and planning skills, and proven independent decision-making capability.
Team Management and mentoring skills Strong problem solving and analytical skills.
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
Knows how/when to apply policy and/or procedures to a variety of situations.
Otsuka America Pharmaceutical, Inc. (OAPI) is a successful, innovative, fast growing healthcare company that commercializes Otsuka - discovered and other product opportunities in North America, with a strong focus on and commitment to neuroscience, cardiovascular and oncologic therapeutic treatments. OAPI is dedicated to improving patient’s health and the quality of human life.