Salary is commensurate with experience and education
As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem solving skills and dedication to build stronger minds and a healthier world.
UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty. All of which has allowed the UW to be nationally recognized as a Great College to Work For for four consecutive years.
The University of Washington Center for Biomedical Statistics (CBS) within the Department of Biostatistics has an outstanding opportunity for a full-time Project Manager.
The Project Manager will provide senior operational leadership and direction for the development and growth of the data coordination centers (DCC) within CBS. Successful candidates will manage multiple projects in various phases of development. With the guidance of the Faculty Director, they will also ensure successful delivery and execution of clinical trial operations, including personnel management, financial management, and regulatory compliance. Develop and implement programmatic, strategic, and operational approaches to advance the quality and efficiency of clinical trials and clinical research networks. Use innovative program solving approaches to non-routine issues. Provide guidance to the clinical, programming, administration and statistical staff.
This position is the lead data and operations manager for large, multidisciplinary clinical trials and requires significant experience in the management of scientific studies and the operational aspects of a large center. This position will collaborate and negotiate directly with federal sponsors and other academic institutions as well as with investigators and departments across UW. The work performed at the UW involves complex data analysis pipelines, advanced computer programming deliverables, and thorough knowledge of HIPAA and other Human Subjects regulations.
The CBS is a nationally recognized leader in clinical trials and has won and completed federal grants in excess of $75M in the last five years. The CBS is a critical resource for investigators at UW and nationally who are striving to improve clinical approaches in emergency medicine, cardiovascular disease, and other areas.
Manage each phase of multiple research projects, from identifying and defining the initial concept/problem through protocol design and development. Oversee and collaborate in development of case report forms, manuals of operation, data management plans, regulatory approvals, clinical trial materials. Oversee the management of trials from start-up, implementation, monitoring through closeout.
Build/maintain a positive and productive working environment for all staff, faculty and students of the CBS. Provided day-to-day guidance with administrative, clinical, programming and statistical staff (10+ FTE) including hiring, training/mentoring, performance reviews, and enforcing University policies. Define staff roles. Organize and lead research staff meetings regularly or as needed.
Direct monitoring of clinical trials and formation of the reports with clinical and statistical staff for enrollment, compliance monitoring, DSMB, NIH and other sponsors. Preparation or oversee preparation of a variety of reports to sponsors, regulatory bodies, and other groups. Establish auditing plans, site visit schedules and reporting. Participate in site/audit visits. Use findings to change data collection or interpretation. Oversee and collaborate in development of case report forms, manuals of operation, data management plans, regulatory approvals, clinical trial materials.
Provide fiscal oversight for both the CBS and study budgets and report to the study governing bodies and Director / Principal Investigator.
Facilitate communications of committees, include the following committees: Management, Executive, DSMB, and other project-specific committees.
Identify problems within clinical trials or management of trials and provide innovative problem solving approaches to non-routine issues and/or collaborate with study investigators / staff to resolve.
Participate in manuscript preparation from development of a hypothesis through publication.
Organize and facilitate applications for new research project initiatives and grants.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Master's in a clinical field or in the management of multi-disciplinary scientific research and at least nine years of progressively responsible experience in clinical research operations in a coordinating center in the contract research, pharmaceutical, medical device, or biotechnology industry or in an academic research organization.
Ability to function effectively in a leadership role in an academic organization.
Strong knowledge of clinical trial operations, including project management, data management, site management and clinical monitoring, safety surveillance and regulatory services.
Strong knowledge of regulatory requirements applicable to the conduct of clinical trials (GCP, HIPAA, human subject protections, etc.)
Proven organizational, planning prioritization, problem solving, facilitation, negotiation and decision- making skills.
Excellent communication and people skills.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Experience with REDCap (www-projectredcap.org) as a user or with database and case report form creation.
CONDITIONS OF EMPLOYMENT
Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check.
Application Process: The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Workforce Authorization, Criminal Conviction History, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select Apply to this position. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your My Jobs page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergra...duate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.