IIT Program Manager

The University of Kansas Cancer Center

The University of Kansas Cancer Center is seeking an IIT Program Manager to be responsible for planning, executing and managing operational aspects of Investigator Initiated Trials (IIT) clinical research projects managed by the Clinical Trials Office (CTO). This position will serve as a leading contributor to the ongoing development of the University of Kansas Cancer Center (KUCC) IIT program, its services and products, in accordance with the KUCC strategic plan. From IIT protocol conception to trial completion, throughout the life cycle of the project, this position manages resources, deliverables, timelines, oversight of project costs, contracts and agreements. The IIT Program Manager will be responsible for internal and external stakeholder relationships through the Investigator Sponsored Research Unit (ISRU) by serving as primary point of contact for all assigned projects. This position reports to the Senior Executive Director of the CTO.

Position Responsibilities:
• IIT Expert Liaison Collaborate and communicate with Principal Investigator and ISRU members on all aspects of IIT protocol management and trial conduct, including matters related to prioritization, problem-solving and resourcing. Effectively manage communications with internal and external stakeholders, across institution departments (e.g. Investigational Pharmacy), and laterally across the CTO team as well as up and down reporting structures within the CTO. Primary contact for all assigned IIT protocols (e.g. logistical project-related concerns). Ability to motivate the ISRU to commit to a common purpose, performance goal and approach for which all hold themselves individually and mutually accountable. Manage contractual and organizational client expectations. Delegate activities while retaining ownership. Liaise with CTO management to optimize performance of ISRU. Actively participate when needed in Project Director, Departmental, Coordinator, Regulatory Team and Staff meetings. Develop and maintain clinical and operational relationships with staff in the network for multisite IITs where we are the lead center.

• IIT Clinical Project Management Aid in study budget preparation and resource planning to accomplish study objectives. Collaborate with Clinical staff to prepare and present prospective trials to the Executive Review Committee (ERC). Attend and present status updates at applicable Disease Working Group (DWG) meetings. Accomplish project goals through effective team leadership. Support upper management through the use of effective tracking tools to provide consistent and accurate project status. Partner with CTO Clinical Site Management with planning, organizing and scheduling of monitoring visits. Promote project continuity by facilitating the internal kick-off meeting (KOM), site initiation visits (SIVs) and other training as required by protocol updates in the event of multisite trials. Manage processes pertaining to adverse events and protocol deviations to ensure timeliness, accuracy and completeness of reporting on IITs. Identify IIT project risks and suggest possible solutions; manage problem resolution through expedient and corrective means. Ensure each step in the study start-up process is complete and appropriately documented before the study is activated and patient recruitment begins. Oversee and report on the progress of the study from activation until termination.

• IIT Project Management of Biostatistics/Data Management Facilitate collaborations with Biostatistics faculty and staff, on tasks such as: study design, budget estimates, database development, eCRF creation, interim analysis requirements, data cleaning procedures, analysis requests, abstract writing, manuscript writing, FDA submissions and filings. Collaborate with Biostatistics faculty and staff to maintain and update standardized eCRF repository (eCRF Content Toolkit). Communicate with Biostatistics periodically to confirm and provide updates on new and ongoing projects. Provide Quality Data Management by reviewing data periodically with the data management team.

• Direct Supervision Perform functional management duties as the IIT program develops; Functional management includes developing direct reports through initial on-board training, regular 1:1 mentoring and coaching, career path management, continuing education and delegation of responsibility.

Position Requirements:

• Bachelor’s degree in life sciences or related field. Minimum of 3 years clinical trial experience within the pharmaceutical industry or academia. Minimum of 2 years clinical project management experience within the pharmaceutical industry or academia.
• Prior experience with FDA submission and filings. Knowledge of FDA regulations and ICH GCP guidelines.
• Excellent written and oral communication skills.
• Working knowledge of database software for managing projects and resources.
• Demonstrated ability to work independently and collaboratively.
• Detail oriented and proven ability to multi-task; excellent organizational skills.
• Excellent understanding of Clinical Research study start-up process.
• Prior experience in the field of oncology clinical research.
• Demonstrated ability to manage several project teams and competing priorities simultaneously.
• Working knowledge of the clinical research budgeting process and negotiations
• Experience in a clinical setting.
• Masters or higher degree, Project Management Professional (PMP) Certification or related certification and prior functional management experience preferred.

KU Medical Center 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 disability status, or genetic information. br>
For more information or to apply, please go to: and reference position number: J0030223.