SENIOR CLINICAL TRIAL 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.
* Develops clear and measurable project management plans; Defines 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.
* Establishes project metrics and project schedules with client representatives. Provides at least monthly project updates.
* Facilitate case report form development, review, approval, and finalization with the Data Management Team
* Development of Manual of Procedures and site study binder 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
* Coordination of 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: * Bachelor's Degree with 5-7 years of related experience; or combination of equivalent education/experience.
* 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
The candidate must be a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables. This includes coordination with the clinical team, authoring manual of procedures for the conduct of the trial, attending and participating in trial-kick-off meetings (requiring limited travel to participating sites), and providing technical leadership and scheduling for the team to ensure deliverables. This candidate must also have a thorough knowledge of Federal Regulations and ICH-GCP guidelines, and a comprehensive understanding of clinical trial processes, and the conduct of clinical studies.
Reference Number: 40-25729
Salary Grade: 028
Employment Type: Exempt
Org: CI-Center for Cellular Immunotherapy
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: I-Technical/Professional Research