Clinical Program Manager

Job Description Role Summary \n The Clinical Program Manager will work with the Head of Clinical Research and Development and VP of Research to operationalize and execute strategic plans to advance the mission of the Foundation, coordinating an active portfolio of clinical trials and clinical research initiatives. The qualified individual will directly contribute to the implementation, oversight, and advancement of clinical activities and research projects across the Foundation’s priority areas, including the Lustgarten United Clinical Information Database (LUCID) and Lustgarten Research Community. \n \n The Clinical Program Manager will be expected to have excellent interpersonal and communication skills and interact effectively with all stakeholders, vendors and collaborations – internally and externally, scientific and non-scientific. They are also expected to have a solid background in program management, as well as data management and regulatory review processes. They will report to Head of Clinical R&D and working closely with the Grants Manager, Program Scientist, VP of Research and Chief Medical Advisor. \n \n Specific Functions/Activities Summary \n · Work closely with the Head of Clinical R&D, VP of Research, Chief Medical Officer and external collaborators on the development and management of Lustgarten’s expanding clinical programs and consortia, aiming for increased efficiency, innovation and alignment with strategic objectives. \n · Work closely with the Head of Clinical R&D, Grants Manager and AACR Project GENIE on the development. oversight and integration of Lustgarten’s clinical data repository and analytic platform: LUCID. \n \n · Clinical Program Management: \n o Work with the Grants Manager and Program Scientist to develop methods for oversight of the Lustgarten Research Community (LRC), the Foundation’s network of research investigators and collaborators. \n o Work with the Grants Manager and AACR Project GENIE on developing internal and external standard operating procedures. \n o Lead development of project and program-level milestone tracker that integrate across Lustgarten’s clinical initiatives. \n o Work with AACR Project GENIE, the Program Scientist and Head of Clinical R&D to establish and manage scientific, operational and technical working groups related to LUCID and Lustgarten’s clinical programs. \n o Work closely with the Program Scientist, Grants Manager and Head of Clinical R&D to oversee the Clinical Accelerator Initiative review process as well as ensuring timely activation and delivery of supported trials. This will include progress report review and integration with LUCID. \n \n · Regulatory and Data Management: \n o Support AACR Project GENIE and the Grants Manager with onboarding research project teams the shepherding them through regulatory review process. This will include informed consent form and/or IRB waiver review. \n o Collaborate with the AACR Project GENIE on the data upload and quality review process. This will include working directly with research projects teams to ensure accurate and timely delivery of datasets. \n o Collaborate with AACR Project GENIE, the Head of Clinical R&D and the Program Scientist on the identification, solicitation and prioritization of datasets for LUCID. This includes supporting research project teams on developing budget proposals, as needed. \n \n Qualifications : \n · 5 years of clinical research management experience in either an industrial or academic capacity; experience in oncology strongly preferred. \n · Bachelors’ degree in a life science discipline; advanced degree and knowledge of cancer biology relating to pancreatic cancer highly desirable. \n · Exceptional project management skills and experience with running cross-functional clinical research initiatives and teams. \n · Experience with stakeholder and vendor management, including oversight of Contract Research Organizations. \n · Experience with clinical trial data management and affiliated regulatory processes; knowledge of fundamentals of contracting for clinical data-sharing. \n · Excellent communication, organizational and relationship-building skills. \n · Ability to prioritize, multitask and meet competing deadlines; capacity to independently and creatively troubleshoot. \n · Ability to seamlessly transfer skillsets between various projects and initiatives. \n · Desire to take on increasing levels of responsibility and adapt to a dynamic research landscape, growing into the position as the organization’s needs evolve. \n \n The Company requires that all individuals, subject to certain limited exceptions, be fully vaccinated against COVID-19. The Company will consider requests for reasonable accommodations regarding this requirement. \n \n The base salary range for this role is $120,000 - $160,000. Offers are determined by depth of experience in pancreatic cancer research and scope of leadership.aa415a4b-8b21-40fc-a65c-70d2b25ca29a