Clinical Research Project Manager A

Upenn; Philadelphia (Philadelphia County); On-site; USD 63,000 - 71,000; Full time

Job summary

University of Pennsylvania's Perelman School of Medicine in Philadelphia, PA seeks a Project Manager within Radiology RADCORE to oversee clinical trials, coordinate study teams, and ensure regulatory compliance.

The role focuses on protocol development, consent forms, CRFs, budgets, recruitment strategies, and collaboration with investigators and sponsors. Strong planning, communication, and regulatory knowledge are essential; bachelor’s degree and 3–5 years of experience required.

Qualifications

• Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required.
• Strong planning and organizational capabilities along with attention to detail, excellent follow through and problem-solving skills necessary.
• Must be effective in setting and meeting personal short and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously.
• Knowledge of regulatory processes is required.
• Excellent written and verbal skills required.

Responsibilities

• Provide project management and regulatory support and expertise associated with clinical trials for the Department of Radiology Clinical Imaging Service Center (RADCORE).
• The Project Manager will manage/supervise the study teams assuring that each clinical trial meets expectations and that they are conducted in accordance with the specific clinical protocol as approved by the Investigator/Sponsor, study team and in accordance with all regulatory organizations.
• Lead team meetings, drive study timelines, recruitment, and overall performance.
• Generate study specific plans and documents, provide input and management of study budgets, and ensure consistent use of study tools and training materials and compliance with standard processes.
• Provide leadership and guidance to research personnel in day-to-day operational activities.
• Perform regulatory duties including regulatory oversight, regulatory submissions, and compliance checks.
• Participate in documentation of best practices and SOPs.

Skills

Project management

Regulatory knowledge

Communication

Detail oriented

Problem solving

Planning and organization

Education

Bachelor of Science

Job description

**Job Description Summary**As part of the Department of Radiology, the Clinical Imaging Service Center (RADCORE) supports a diverse group of investigators, involving work on a wide spectrum of investigator and industry initiated clinical trials of varying complexities. Project Manager work includes overall management of research projects conducted with collaborators both internal and external to the University. Leads development of key study documents including protocol, consent forms, and CRFs, supervision of research support staff, regulatory submissions, recruitment strategy. Responsibilities may also include supporting grant writing, analyzing qualitative and quantitative data, cultivating close relationships with community partner organizations, and drafting/editing manuscripts for submission to peer-reviewed journal.**Job Description****Job Responsibilities**The Project Manager will provide project management and regulatory support and expertise associated with clinical trials for the Department of Radiology Clinical Imaging Service Center (RADCORE). The person will work closely with the RADCORE Program Manager to support a diverse group of investigators and coordinators, involving work on a wide spectrum of investigator and industry initiated clinical trials of varying complexities. Involvement will range from consulting to serving as the project manager for a study having primary responsibility with respect to execution and operational planning of the studies and accountability for results. The Project Manager will manage/supervise the study teams assuring that each clinical trial meets expectations and that they are conducted in accordance with the specific clinical protocol as approved by the Investigator/Sponsor, study team and in accordance with all regulatory organizations. S/he will play a key role in study start-up, intake & feasibility for many studies. The Project Manager will provide oversight and support for each study team, lead team meetings, drive study timelines, recruitment, and overall performance. S/he will generate study specific plans and documents, provide input and management of study budgets, and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. S/he will lead problem solving and resolution efforts, and review study status and monitor reports to identify and address possible issues. S/he will provide leadership and guidance to research personnel in their day-to-day operational activities. S/he will perform regulatory duties including regulatory oversight, regulatory submissions, and compliance checks. S/he will participate in documentation of best practices and SOPs. Job ResponsibilitiesManages project/program activities and implements protocols; develops, implements and manages work plans and timeframes in order to ensure project goals. Communicates project/program activities to ensure clear, coordinated project related communications Supervises assigned research support and or laboratory personnel; delegates and coordinates tasks based on developed plans Provide technical leadership and consultation related to project/grant proposals/ manuscripts/animal protocol development, advises those associated with projects (PI) regarding project status Oversee the delivery of patient care as defined in the study protocols and manage/supervise the study teams assuring that each clinical trial meets expectations and that they are conducted in accordance with the specific clinical protocol as approved by the Investigator/Sponsor, study team and in accordance with all regulatory organizations. Play a key role in study start-up, intake & feasibility for many studies Provide oversight and support for each study team, lead team meetings, drive study timelines, recruitment, and overall performance. Generate study specific plans and documents, provide input and management of study budgets. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Lead problem solving and resolution efforts, and review study status and monitor reports to identify and address possible issues.Provide leadership and guidance to research personnel in their day-to-day operational activities. Perform regulatory duties including regulatory oversight, regulatory submissions, and compliance checks. Participate in documentation of best practices and SOPs. Other duties and responsibilities as assigned.Contingent Upon Grant Funding**Qualifications** Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required. Strong planning and organizational capabilities along with attention to detail, excellent follow through and problem-solving skills necessary. · Must be effective in setting and meeting personal short and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously. · Successful candidates will have the ability to anticipate problems relating to projects and to develop and implement solutions. · Flexibility and the drive to meet project deadlines required. Knowledge of regulatory processes is required. · Excellent written and verbal skills required.**Job Location - City, State**Philadelphia, Pennsylvania**Department / School**Perelman School of Medicine**Pay Range**$63,085.00 - $70,958.00 Annual RateSalary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.