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Job Profile Title

Manager Research Project B

Job Description Summary

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.

Responsibilities Include:

• 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.

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. Position is contingent upon funding

Excellent communication and training skills, attention to detail, excellent organizational and time management skills, ability to work independently and as a team member. The successful candidate will assure compliance with all applicable regulatory requirements, SOPs, agreements, etc.

Job Description

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.

Responsibilities Include:

• 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.

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. Position is contingent upon funding

Excellent communication and training skills, attention to detail, excellent organizational and time management skills, ability to work independently and as a team member. The successful candidate will assure compliance with all applicable regulatory requirements, SOPs, agreements, etc.

Qualifications

Bachelors Degree with 5-7 years of related experience or equivalent combination of education and experience is required

Working Conditions

Office, library, computer room

Physical Effort

Typically sitting at a desk or table; Occasional lifting 25 lb. or less; Typically standing or walking

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$59,703.00 - $113,435.00

Affirmative Action Statement

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

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.