Clinical Research Project Manager B/C

Trustees of University of Pennsylvania; Philadelphia (Philadelphia County); On-site; USD 90,000 - 130,000; Full time

Job summary

The University of Pennsylvania is seeking a Clinical Research Project Manager B/C to oversee complex clinical research programs across multiple sites, domestically and internationally. You will coordinate study start-up, daily operations, site communications, enrollment, and troubleshooting while ensuring compliance with protocols and SOPs.

Lead strategic planning for budgets and grants, supervise project staff, and facilitate regulatory submissions, data quality, and dissemination of results

Qualifications

• Experience leading multicenter clinical research projects.
• Ability to manage budgets, grants, and regulatory submissions.
• Strong coordination with internal teams and external partners.
• Experience with data quality and regulatory compliance.

Responsibilities

• Manage single and/or multi-site clinical research projects (start-up, operations, site communications, enrollment, troubleshooting).
• Develop and review regulatory submissions and study documents.
• Assist with budgeting, grant writing, and invoicing related to trials.
• Supervise research staff and ensure protocol compliance and QA.
• Contribute to dissemination of study results.

Skills

Clinical research

Project management

Regulatory compliance

Grant writing

Job description

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes:

• excellent healthcare and tuition benefits for employees and their families
• generous retirement benefits
• a wide variety of professional development opportunities
• supportive work and family benefits
• a wealth of health and wellness programs and resources
• and much more

Posted Job Title

Clinical Research Project Manager B/C

Job Profile Title

Clinical Research Project Manager B

Job Description Summary

Clinical Research Project Manager B - Oversees complex clinical research projects with limited oversight from senior leadership. Coordinates multicenter studies, ensures adherence to protocols and SOPs, and develops quality assurance processes. Contributes to protocol and budget development, supervises project staff, and manages performance. Facilitates grant applications, stakeholder communication, and compliance with regulatory and institutional requirements.

Clinical Research Project Manager C - Provides leadership for large and complex clinical research projects, guiding study strategy and operations across multiple sites both domestic and international. Oversees project design, documentation, and compliance, and ensures quality data collection and reporting. Supervises project teams, manages grants and budgets, and leads dissemination of study results through publications and presentations. Builds collaborations with external partners and funding agencies.

Job Description

Job Responsibilities

Clinical Research Project Manager B:

Manage single and/or multi-site clinical research projects (including study start up, daily operations, external site communications, recruitment and enrollment, and troubleshooting; quality assurance and quality control; study close out activities).

Develop, create and review regulatory submission and study documents/tools, including protocols, consents, annual reports, source docs, training slides, manual of procedures, Data Safety Monitoring Board charter, clinical report forms, standard operating procedures. Provide assistance with Investigtional New Drug, Investigational Device and Clinical Trial Agreement exemption determinations.

Assist/conduct pre-award finance activities medical record abstraction/medicare coverage analysis development, clinical trials management system registration, research billing number, driving contract timelines, budgeting input or development, grant writing assistance); and/or post award finance activities (invoicing, billing review).

Staff supervision: Train direct and/or indirect research staff in program/division/dept procedures as required per protocol(s). Includes onboarding and training, data and lab management, protocol compliance and quality control/quality assurance, human subjects protection and good clinical practice, and project assignments/staff mentoring/biannual performance appraisal completion.

Perform additional duties as assigned.

Clinical Research Project Manager C

Manage mostly complex, multi-site clinical research projects (including study start up, daily operations, external site communications, recruitment and enrollment, and troubleshooting; quality assurance and quality control; study close out activities).

Develop, create and review regulatory submission and study documents/tools, including protocols, consents, annual reports, source docs, training slides, manual of procedures, Data Safety Monitoring Board charter, clinical report form, standard operating procedure. Provide assistance with investigational new drug, investigational device and clinical trial agreement exemption determinations.

Assist/conduct pre-award finance activities (medical record abstraction/medical coverage analysis development, registration, research billing number, driving contract timelines, budgeting input or development, grant writing assistance); and/or post award finance activities (invoicing, billing review).

Staff supervision: Assis