Clinical Research Project Manager A

University of Pennsylvania Perelman School of Medicine

4d • $63,085 - $75,000 • Onsite

About The Position

As part of the Department of Medicine, the DOM Clinical Trials Unit supports a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities. Project Manager work includes overall management of research projects, supervision of research staff, regulatory submissions, recruitment strategy, and development of key study documents include protocol, consent, and CRFs. Our projects occur throughout the Department of Medicine including Cardiology, Pulmonary, Rheumatology, Translational Medicine, Gastroenterology, Infectious Disease, General Medicine, Sleep, HemOnc, Endocrine, Renal and Geriatrics. The Project Manager will provide project management and regulatory support and expertise associated with clinical trials for the Penn Department of Medicine’s Clinical Trials Unit. The person will work closely with the Director of Clinical Research Operations to support a diverse group of investigators and coordinators, involving work on a wide spectrum of clinical trials ranging from phase I-IV, investigator/industry-initiated, different disease states and 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 oversee the delivery of patient care as defined in the study protocols. 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 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 A will continue to have Research Coordinator duties as needed to meet the needs of the CTU. 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. S/he will participate in the Department of Medicine research initiatives including the Training Program and Activation of Clinical Research at Penn Affiliate Hospitals.

Requirements

• Bachelor's Degree with 3-5 years of related experience or equivalent combination of education and experience is required
• Strong planning and organizational capabilities
• 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
• 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 required
• Excellent written and verbal skills required

Responsibilities

• Overall management of research projects
• Supervision of research staff
• Regulatory submissions
• Recruitment strategy
• Development of key study documents include protocol, consent, and CRFs
• Provide project management and regulatory support and expertise associated with clinical trials
• Oversee the delivery of patient care as defined in the study protocols
• 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 Sponsor, study team and in accordance with all regulatory organizations
• Play a key role in study start-up, intake & feasibility for many studies
• Continue to have Research Coordinator duties as needed to meet the needs of the CTU
• 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
• 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
• Participate in the Department of Medicine research initiatives including the Training Program and Activation of Clinical Research at Penn Affiliate Hospitals

Benefits

• Excellent healthcare benefits
• Tuition benefits for employees and their families
• Generous retirement benefits
• Wide variety of professional development opportunities
• Supportive work and family benefits
• Wealth of health and wellness programs and resources
• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
• Flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars
• Tuition assistance for employee, spouse, and dependent children
• Dependent children are also eligible for tuition assistance at other institutions
• Generous retirement plans
• Penn’s Basic, Matching, and Supplemental retirement plans
• Substantial amount of time away from work
• Long-Term Care Insurance
• Wellness and Work-life Resources
• Professional and Personal Development resources
• Access to a wide range of University resources as well as cultural and recreational activities
• Discounts and Special Services
• Flexible Work Hours
• Penn Home Ownership Services
• Adoption Assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level