Sr Program Manager
Plans, develops, implements, and coordinates projects for the Center for HPV Prevention (CHPVP) that houses the New Mexico HPV Pap Registry (NMHPVPR).
Designs and implements systems to assess, collect, maintain, and analyze data; generates interim progress reports, final reports, evaluation, and other information related to projects and programs of the CHPVP and NMHPVPR.
Establishes and implements short- and long-range goals, objectives, policies, and compliance and operating procedures; monitors and evaluates operational effectiveness and drives changes required for improvement of the CHPVP and NMHPVPR programs.
Manages, and oversees the daily administrative components of CHPVP and NMHPVPR programs and projects.
Establishes and maintains staffing and organizational structures to effectively accomplish the CHPVP and NMHPVPR functions and recruits, trains, supervises, and evaluates program and project staff.
Develops and implements systems, protocols and processes to establish and maintain budgets, protocols and project records for the CHPVP and NMHPVPR.
Acts as a liaison for outreach activities of the CHPVP and NMHPVPR programs and projects.
May engage in contract negotiations, oversees protocol development and implementation and evaluates the performance of research projects in compliance with local, state, federal and industry sponsors to enable FDA and IRB regulated clinical research and public health surveillance.
Develops and manages budgets for the CHPVPR and NMHPVPR projects and performs periodic fiscal analyses and projections.
Plans and develops strategies for generating resources and / or revenues for projects and contributes to the preparation of contract and / or grant proposals.
Recommends, participates in the development of, and establishes policies and standard operating procedures for the CHPVP and NMHPVPR.
May serve on institutional planning and policy-making committees.
Represents the CHPVP and NMHPVPR programs to various institutional units and external entities, funding agencies, national organizations, and the general public.
Performs miscellaneous job-related duties as assigned.
Developing and working with comprehensive, organized tracking systems for management of large volume program resources including budget preparation and projections for fiscal accountability.
Negotiating contracts and budgets, maintaining study documents, and driving study timelines to successful completion.
Protected health information, electronic medical record review, informed consent, data collection and acquisition.
Operations oversight, investigator and staff training, collaborative clinical and laboratory and site staff management, and facilitating FDA and IRB regulatory approvals in compliance with current GCP Regulations / Guidelines.
Management of clinical / research data across multiple platforms, including training and troubleshooting for endpoint users of data bases / applications and subsequent onboarding data program staff in clinical / research database and application management, generating reports and implementing quality control.
Developing and providing input into program documents (e.g. protocols and procedures, budgets, project schedules, timelines, training materials, study and sponsor reports, monitoring plans) in collaboration with cross-functional team members.
Working with clinical and archival liquid and biopsy specimens using universal precautions and maintaining confidentiality through de-identification and / or secure storage across research protocols.
Development and execution of standard operating procedures and process guidelines for the purpose of training and supervision of employees and evaluation of program effectiveness toward continuous improvements.
Development of source documents used as data collection instruments for detailed medical record review which include coordinating, planning, and reviewing the development and maintenance of comprehensive records and logs resulting in the preparation of activity reports for the Center Director.
Managing and ensuring confidentiality and HIPAA compliance.
Experience understanding federal and state regulations and guidelines pertaining to the conduct of clinical trials in human participants.
National certification from Association of Clinical Research Professionals demonstrating knowledge and high-level experience in clinical research and coordinating and facilitating trial activities in adherence to GCP, under the direction of a principal investigator.
High school diploma or GED; at least 7 years of experience directly related to the duties and responsibilities specified; two of which are management level experience.
Completed degree(s) from an accredited institution that are above the minimum education requirement may be substituted for experience on a year for year basis.
Experience in developing and working with comprehensive, organized tracking systems for management of large volume program resources including budget preparation and projections for fiscal accountability.
Experience negotiating contracts and budgets, maintaining study documents, and driving study timelines to successful completion.
Experience with protected health information, electronic medical record review, informed consent, data collection and acquisition.
Experience in operations management, investigator and staff training, collaborating clinical and laboratory and clinical site staff management, and facilitating FDA and IRB regulatory approvals in compliance with current GCP Regulations / Guidelines.
Experience in the management of clinical / research data across multiple platforms, including training and troubleshooting for endpoint users of data bases / applications and subsequent onboarding data program staff in clinical / research database and application management, generating reports and implementing quality control.
Experience developing and providing input into program documents (e.g. protocols and procedures, budgets, project schedules, timelines, training materials, study and sponsor reports, monitoring plans) in collaboration with cross-functional team members.
Experience working with clinical and archival liquid and biopsy specimens using universal precautions and maintaining confidentiality through de-identification and / or secure storage across research protocols.
Experience in the development and execution of standard operating procedures and process guidelines for the purpose of training and supervision of employees and evaluation of program effectiveness toward continuous improvements.
Experience in the development of source documents used as data collection instruments for detailed medical record review which include coordinating, planning, and reviewing the development and maintenance of comprehensive records and logs resulting in the preparation of activity reports for the Center Director.
Experience managing and ensuring confidentiality and HIPAA compliance.
Experience understanding federal and state regulations and guidelines pertaining to the conduct of clinical trials in human participants.
National certification from Association of Clinical Research Professionals demonstrating knowledge and high-level experience in clinical research and coordinating and facilitating trial activities in adherence to GCP, under the direction of a principal investigator.
Finalists should be prepared to provide official educational transcripts if selected for hire. Applicants must provide names of 3 professional references that the hiring official can contact.
Sr Program Manager • Albuquerque, NM, US