JOB OVERVIEW The Program Manager of the UCSF PrecISE consortium (PM-UPC) will provide strategic and tactical planning, organization and direction to ensure the success of the UCSF consortium in the PrecISE clinical trials program. The PM-UPC manages operations, including those related to administration, compliance, participant recruitment and retention, and sponsor reporting activities.
The PM-UPC will manage a minimum of two Clinical Operations staff. The PM-UPC will provide leadership and support for Airway Center operational and strategic initiatives, particularly as they pertain to operational process and project management.
The important objectives this position is required to achieve are the development of a strong team to ensure that the UCSF consortium is a successful participant in the NHLBI PrecISE program and that the inclusion of two foreign sites is an asset rather than a burden or liability in terms of regulatory difficulties or expense. The PM-UPC will ensure that the UCSF consortium is successful in enrolling participants in the PrecISE trials and that the consortium manages risks associated with regulatory compliance and logistical barriers. Errors, oversights or lack of planning and coordination among consortium sites may result in slow recruitment, or censure by the IRBs or the NIH that could jeopardize funding.
PRECISE NETWORK / CARDIOVASCULAR RESEARCH INSTITUTE The PrecISE Network is an initiative funded by the NIH/NHLBI to advance precision medicine for patients with severe and exacerbation prone asthma. The PrecISE network includes eight centers from academic research institutes in the US and beyond.
The Program Manager of the UCSF PrecISE consortium (PM-UPC) has a key position within the UCSF PrecISE consortium. The consortium was established to ensure strong content area expertise in severe asthma and deep resources for the conduct of complex clinical trials in patients with severe asthma. The UCSF PrecISE consortium is expect to recruit 100 patients with severe asthma in an 18 month period and enroll these patients into a set of adaptive clinical trials that are biomarker driven and designed to allow for treatment changes based on predefined response variables. The UCSF center will provide leadership for the consortium and will be responsive for contacts with the data center and the National Heart, Lung, and Blood Institute (NHLBI). The UCSF PrecISE team works as part of the UCSF Airway Clinical Research Center (ACRC). The ACRC is a specialized clinical research unit that focuses on mechanism-oriented clinical studies of asthma and other airway diseases.
ABOUT UCSF The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences.
REQUIRED QUALIFICATIONS *Bachelor's degree in related area (Biology, Public Health, etc.) and seven years of experience in clinical research, administrative analysis or operations research, and / or equivalent experience / training *Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory requirements *Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Advanced knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems *Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials. Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research *Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex trial design issues *Expert knowledge of MS Office Suite *Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities *In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems *Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings *Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals *In depth ability to work collaboratively with other cross-functional teams. In depth ability to interface, collaborate and influence / persuade other members of an extended study team *Demonstrated ability to organize research work functions in an efficient and effective manner *Great organizational skills applied to personal work and improving organization of assigned staff and trial
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PREFERRED QUALIFICATIONS *Master’s degree in related area (Biology, Public Health, etc.) and more than five years’ experience in clinical research, administrative analysis or operations research; / or equivalent education /experience / training *Research (CCRP, CCRC, CCRA) and/or Project Management (PMP, Six Sigma) Certification
The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.