University of Rochester
Manager, Clinical Trials Proj
University of Rochester, Rochester, New York, United States, 14618
Job Posting
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. Job Location: 265 Crittenden Blvd, Rochester, New York, United States of America, 14642 Opening: Regular Time Type: Time as Reported / Per Diem Scheduled Weekly Hours: As Scheduled Department: 400274 CCRC Work Shift: UR - Day (United States of America) Range: UR URG 113 H Compensation Range: $37.12 - $55.68 The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. Responsibilities
General Purpose: Directs and coordinates all aspects of clinical research trials and acts as a liaison to study leadership and sponsor(s). Ensures study activities are meeting deadlines and manages overall study timeline. Provides oversight and mentoring to junior members of the study team in addition to manages senior members of the team in a supervisory capacity. Essential Functions: Directs the development and execution of clinical trial activities for multi-center industry sponsored trials, including developing and revising study timelines. Engages with Finance for budget development and budget management. May be asked to manage more complex protocols and/or larger scale industry sponsored trials. Mentors, trains, and manages staff, including developing career plans and delivering performance appraisals. Leads internal and external meetings and provides professional direction within clinical trials team. Monitors progress toward meeting team goals and completing action items. Serves as liaison to the Principal Investigator, study leadership, vendors, and sponsor. Oversees entire study team, internal and external, including clinical trial sites, clinical and research laboratories, study medical monitors, biostatistics core, and data management team. Represents study team in meetings. Drafts and/or completes internal review of study protocol and final study documents for review and approval by study leadership. Drafts requests and reports to regulatory agencies, such as IND application, annual IND update to FDA, etc. Plans large scale external meetings. Presents at external study meetings as well as other professional meetings. Other duties as assigned. Minimum Education & Experience
Bachelor's degree and 6 years of relevant experience required Master's degree preferred Or equivalent combination of education and experience Previous leadership experience required Knowledge, Skills and Abilities
Clinical trials project management experience including extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials required Strong communication skills, interpersonal skills, attention to detail, and organization skills required Licenses and Certifications
CCRP - Certified Clinical Research Professional upon hire preferred Certified Project Management Professional (PMP)-PMI upon hire preferred The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create
and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. Job Location: 265 Crittenden Blvd, Rochester, New York, United States of America, 14642 Opening: Regular Time Type: Time as Reported / Per Diem Scheduled Weekly Hours: As Scheduled Department: 400274 CCRC Work Shift: UR - Day (United States of America) Range: UR URG 113 H Compensation Range: $37.12 - $55.68 The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. Responsibilities
General Purpose: Directs and coordinates all aspects of clinical research trials and acts as a liaison to study leadership and sponsor(s). Ensures study activities are meeting deadlines and manages overall study timeline. Provides oversight and mentoring to junior members of the study team in addition to manages senior members of the team in a supervisory capacity. Essential Functions: Directs the development and execution of clinical trial activities for multi-center industry sponsored trials, including developing and revising study timelines. Engages with Finance for budget development and budget management. May be asked to manage more complex protocols and/or larger scale industry sponsored trials. Mentors, trains, and manages staff, including developing career plans and delivering performance appraisals. Leads internal and external meetings and provides professional direction within clinical trials team. Monitors progress toward meeting team goals and completing action items. Serves as liaison to the Principal Investigator, study leadership, vendors, and sponsor. Oversees entire study team, internal and external, including clinical trial sites, clinical and research laboratories, study medical monitors, biostatistics core, and data management team. Represents study team in meetings. Drafts and/or completes internal review of study protocol and final study documents for review and approval by study leadership. Drafts requests and reports to regulatory agencies, such as IND application, annual IND update to FDA, etc. Plans large scale external meetings. Presents at external study meetings as well as other professional meetings. Other duties as assigned. Minimum Education & Experience
Bachelor's degree and 6 years of relevant experience required Master's degree preferred Or equivalent combination of education and experience Previous leadership experience required Knowledge, Skills and Abilities
Clinical trials project management experience including extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials required Strong communication skills, interpersonal skills, attention to detail, and organization skills required Licenses and Certifications
CCRP - Certified Clinical Research Professional upon hire preferred Certified Project Management Professional (PMP)-PMI upon hire preferred The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create
and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.