United States onlyThere’s a reason St. Jude Children’s Research Hospital is consistently ranked on Glassdoor’s “Best Places to Work” list. Actually, there are more than 6,500 reasons. At our world-class pediatric research hospital, every one of our 6,500 professionals shares our commitment to making a difference in the lives of the children we serve. There’s a unique bond when you are part of a team that will stop at nothing to advance the treatments and cures of pediatric catastrophic diseases. The result is a collaborative, positive environment where all employees, regardless of their role, receive the resources, support, and encouragement to advance and grow their careers.
The Clinical Research Project Manager is responsible for overseeing and coordinating all activities for clinical trials at St. Jude. This position works closely with sites and/or the St. Jude study team and appropriate staff in each department at St. Jude to assist with all department operations tasks and requirements. The Project Manager will have responsibility for establishing and meeting timelines for department operations and ensuring the project progresses through all functional working groups within the department from the start of the project through completion.
Job Responsibilities:
Lead institutional as well as St. Jude sponsored, multi-center trials, including regulatory, financial, and administrative aspects of the study.
Provide clinical operations expertise to inform clinical trial operational feasibility and delivery, and development of study recruitment and retention strategies.
Collaborate with pharmaceutical services, study teams, and external stakeholders to forecast study drug needs and develop study-specific supply chain operational plans.
Participate in/guide contract drafting, negotiation, administration and renewal; resource/supply management; budget development and management for clinical trials/studies; and financial tracking and follow-up (e.g., reimbursements) for assigned projects.
Guide engagement between cross-functional teams (e.g., regulatory, finance, biosafety, IS), cross-institutional teams, and external groups (e.g., FDA, NIH) for effective execution of trials/studies.
Drive stakeholder meetings for assigned trials/studies (e.g., PI meetings, CRO trainings, vendor meetings, collaborative study site meetings).
Monitor project progress and site performance, communicate regular updates to leadership teams/key stakeholders, and address risks and delays.
Oversee compliance of assigned projects with regulatory requirements and institutional policies.
Train and mentor teams around clinical trial conduct and project management/coordination.
Assist in development of standard operating procedures, and implementation of process improvements where feasible.
Perform other duties as assigned to meet the goals and objectives of the department and institution.
Maintains regular and predictable attendance.
Minimum Education and/or Training:
Bachelor's degree in relevant area required.
Master's degree preferred.
Minimum Experience:
Minimum Requirement: 5+ years of progressive experience in related area (e.g., study design, clinical project management, research study management).
Experience Exception: Master's degree and 3+ years of experience.
Prior clinical, academic, behavioral, pharmaceutical, biomedical, scientific, or related experience.
Prior experience in coordinating clinical trials/studies in academic center, hospital, or pharmaceutical industry (as applicable).
Clinical research background strongly preferred.
Experience leading complex systems/processes/projects in a technical capacity.
Experience implementing optimization/innovation of institutional systems/processes related to clinical research studies within area.
Proven performance in earlier role.
Compensation
In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $86,320 - $154,960 per year for the role of Project Manager - Clinical Trials Operations.Explore our exceptional benefits!
St. Jude is an Equal Opportunity Employer
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