The Prostate Cancer Clinical Trials Consortium (PCCTC) is hiring an Associate Director, ClinicalOperations as an integral member of the executive team. TheAssociate Director collaborates directly with other PCCTC Directors and the Chief Executive Officer of PCCTC (CEO) to provide leadership in directing and managing the clinical operations activities of the PCCTC including assessing complex issues where analysis and in-depth knowledge of clinical research is required. The Associate Director is responsible for working closely with the Director to develop and execute strategic planning and programmatic initiatives, including communications, with direct impact on the clinical research operations of the organization.
More information about thePCCTC :
PCCTCwas initiated in 2005 by the Prostate Cancer Foundation (PCF) and the U.S. Department of Defense (DOD) Prostate Cancer Research Program (PCRP) in response to critically unmet needs in prostate cancer clinical research identified by physician investigators and patient advocates. Established as an independent entity in 2014, thePCCTCis now the nations premier multicenter Clinical Research Organization (CRO) specializing in cutting-edge prostate cancer research. ThePCCTCworks together with distinguished investigators on a single mission: to design, implement and complete hypothesis-driven prostate cancer research, translating scientific discoveries to improved standards of care. To fulfill its mission, thePCCTCdeveloped a unique infrastructure, which has fostered a culture of transparent project co-development between investigators, research sites and industry partners.
Collaborate directly with the CEO PCCTC, PCCTC Research Site Leadership and other PCCTC Directors to provide leadership in developing and improving the conduct of all research in the PCCTC.
Help lead implementation of research vision and goals.
Provide oversight and management of the day-to-day operations for a portfolio of early phase clinical trials.
Develop and lead a team of Project Managers and Project Associates, making strategic staffing decisions and supporting growth within the division.
Ensure the highest data quality, operations and staff management, quality assurance, regulatory compliance, and strategic planning.
Collaborate with other PCCTC Directors and with project teams to ensure execution of studies in compliance with quality standards (including ICH GCP, local regulations and company Standard Operating Procedures (SOPs)), on schedule and on budget.
Collaborate and integrate with PCCTC stakeholders (sites, leadership, industry) to improve the quality of clinical research and implement policies and procedures for improvement of the PCCTC clinical research portfolio.
Plan and align company initiatives, including evaluating risks, resources, and funding to develop and execute research to achieve company and study-specific objectives.
7-10 years of directly related clinical research administration experience.
4-7 years of management and/or leadership experience.
A Bachelor's degree or equivalent experience is required; a Masters degree is preferred.
Comfortable working in a fast-paced environment.
Strong organizational, prioritization, and project management skills.
Strong computing skills including proficiency in MS Office products.
Excellent interpersonal, verbal and written communication skills.
Ability to solve problems by using a logical, systematic, sequential approach.
Thorough knowledge of the Code of Federal Regulations, Good Clinical Practice, and Human Subjects Protection.
Experience working with prostate cancer clinical trials and/or multicenter projects is a plus.
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