Clinical Research Project Manager A

The University of Pennsylvania, a world-renowned leader in education, research, and innovation, is the largest private employer in Philadelphia. Consistently ranked among the top 10 universities in the U.S., Penn offers a unique working environment within the city of Philadelphia, combining a beautiful urban campus with access to diverse educational, cultural, and recreational activities.

About the Role

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, across different disease states and varying complexities. The Project Manager will provide project management and regulatory support for these trials, working closely with the Director of Clinical Research Operations and a diverse team of investigators and coordinators.

Responsibilities

• Provide project management and regulatory expertise for clinical trials, ranging from consulting to serving as the primary project manager for studies.
• Oversee the delivery of patient care as defined in study protocols, ensuring compliance with the protocol, sponsor requirements, and regulatory standards.
• Manage and supervise study teams, ensuring trials meet expectations and are conducted in accordance with approved protocols and regulations.
• Lead study start-up, intake, and feasibility processes for multiple studies.
• Maintain Research Coordinator duties as needed to support the Clinical Trials Unit (CTU).
• Provide oversight and support for study teams, lead team meetings, and drive study timelines, recruitment, and overall performance.
• Generate study-specific plans and documents, manage study budgets, and ensure consistent use of study tools, training materials, and compliance with standard processes and policies.
• Lead problem-solving and resolution efforts, review study status, and monitor reports to identify and address potential issues.
• Provide leadership and guidance to research personnel in their day-to-day operational activities.
• Perform regulatory duties, including oversight, submissions, and compliance checks.
• Participate in documenting best practices and standard operating procedures (SOPs).
• Contribute to 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 an equivalent combination of education and experience.
• Strong planning, organizational, and problem-solving skills, with meticulous attention to detail and excellent follow-through.
• Ability to set and meet personal short- and long-term goals while managing multiple project tasks simultaneously.
• Flexibility and drive to meet project deadlines.
• Knowledge of regulatory processes.
• Excellent written and verbal communication skills.

Position contingent upon funding.

Pay

$63,085.00 - $75,000.00 Annual Rate. Salary offers are based on the candidate’s qualifications, experience, skills, and education, aligned with external market data and internal peer comparisons.

Benefits

• Health, Life, and Flexible Spending Accounts: Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits. Flexible spending accounts for eligible health care and dependent care expenses.
• Tuition Assistance: Exceptional tuition benefits for employees, spouses, and dependent children at Penn and other institutions.
• Retirement Plans: Generous retirement savings options, including Basic, Matching, and Supplemental plans with pre-tax or Roth contributions. Investment options through TIAA and Vanguard.
• Time Away from Work: Substantial paid time off for vacations, personal affairs, illness, or injury.
• Long-Term Care Insurance: Coverage for long-term care services at home, in the community, or in nursing facilities. New hires are exempt from underwriting requirements.
• Wellness and Work-Life Resources: Programs and resources to support health, family, and work-life balance.
• Professional and Personal Development: Resources to advance personal and professional growth.
• University Resources: Access to libraries, athletic facilities, arboretum, art galleries, and cultural and recreational activities, many of which are free for employees and their families.
• Discounts and Special Services: Savings on arts and entertainment, transportation, mortgages, cellular phone plans, movie tickets, theme parks, and new cars from Ford and General Motors.
• Flexible Work Hours: Creative approaches to work schedules, locations, and job structures to promote work-life balance.
• Penn Home Ownership Services: Forgivable loans for eligible employees buying a home or residing in West Philadelphia, applicable to closing costs or home improvements.
• Adoption Assistance: Reimbursement for qualified expenses related to the legal adoption of an eligible child, up to two adoptions per household.