SR CLINICAL PROJECT MANAGER
Duties: The Senior Clinical Trial Project Manager will independently manage multiple Phase I-Phase II Penn-Sponsored clinical research studies in order to ensure execution of clinical research and oversee clinical studies from concept to final close, including study start-up activities, study monitoring activities, data collection, project maintenance and project close-out activities.
The Sr. Clinical Project Manager will be responsible for the cross-functional team's compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines and other applicable regulations. The Sr. Clinical Project Manager is responsible for the overall execution of the project and may be the principal liaison to ensure effective and timely communication of project progress, issues, and plans for resolution of those issues.
* Develop clear and measurable project management plans; Define timelines, milestones, and limitations to project
staff and study sites.
* Monitor project status and timelines
* Manage clinical projects/programs, including deliverables from all functional areas and vendors in accordance with contractual timelines and sponsor specifications.
* Establish project metrics and project schedules with client representatives. Provide at least monthly project updates.
* Facilitate case report form development, review, approval, and finalization with the Data Management Team
* Development of Manual of Procedures (as applicable) and site study binders including all required Sponsor Forms/Templates
* Support clinical development of protocol/consent form documents
* Facilitate local regulatory review committee approvals as required for multisite trials
* Coordinate site initiation visit/site training
* Review/process protocol exceptions/deviations
* Prepare and process DSMB Reports; Organize and coordinate DSMB Meetings
* Reporting of study progress and subject statuses; provide IND summary information for the IND annual report
* Review/report the status of case report form completion and data query resolution
* Develop and provide study and/or protocol amendment training to sites
* Manage/maintain the Sponsor Trial Master Files for each project/site
* Participate in SOP development.
Qualifications: A Bachelor's degree and 5 years to 7 years of experience or equivalent combination of education and experience required.
*Knowledge of FDA regulations and GCP-ICH guidelines; and comprehensive understanding of clinical trials processes and the conduct of clinical research studies.
*Previous Project Management experience preferred. The candidate must possess and have demonstrated the following skills:
*Ability to manage projects independently
*Strong problem-solving and organizational skills
*High attention to detail
*Demonstrated ability to manage multiple tasks simultaneously and complete work within allocated time frames
*Excellent oral and written communication skills
*Excellent organizational and time management skills
Reference Number: 40-28309
Salary Grade: 028
Employment Type: Exempt
Org: CI-Center for Cellular Immunotherapy
Job Family: I-Technical/Professional Research