Clinical Research Project Manager B/C - Logo

About the role

This position supports clinical research studies within the Cardiovascular Division of Penn Presbyterian Medical Center (PPMC). The role may be filled at either the Project Manager B or Project Manager C level, contingent upon favorable funding. Both levels serve as primary project managers for assigned studies with accountability for study execution, operational planning, and overall performance including enrollment. The position coordinates complex study activities across multidisciplinary teams including investigators, coordinators, core labs, and external collaborators, ensuring studies are conducted in accordance with protocol requirements, sponsor expectations, and all applicable regulatory and institutional guidelines. The role functions with a high degree of independence but escalates strategic decisions to senior leadership (e.g., Administrative Director).

Responsibilities

Clinical Research Project Manager B

• Independently manage complex, multi-site cardiovascular clinical research studies in collaboration with the Principal Investigator, including daily operations, study coordination, recruitment/enrollment oversight, and troubleshooting in accordance with Good Clinical Practice (GCP) and all applicable regulatory requirements.
• Supervise, manage, and mentor study teams including onboarding, training, workload management, and performance oversight; develop and drive study timelines, recruitment strategies, and operational plans.
• Assist in research studies using approved protocols according to GCP; familiarize with all components of study protocols by review of study; attend Investigators Meetings.
• Assure accurate completion and updates of the Delegation of Duties and Authorized Signatures Form; confer with the pharmacist as needed to assure availability of study drug.
• Create and maintain research data and regulatory files.
• Timely initiation of screening and enrolling patients; screen to identify potential patients for specific studies, determine patient eligibility by communicating with physicians, clinical staff, and reviewing medical records to validate potential patient data against Inclusion/Exclusion checklists.
• Recruit patients, explain protocol and consent forms; assure original signed consents are maintained in the study binder.
• Complete screening/enrollment logs and submit to sponsor as protocol requires.
• Complete all source documents and worksheets; complete and/or enter all clinical record forms (CRFs); create and maintain subject binders; obtain records required to complete CRFs.
• Assure inclusion of enrollment information, research orders, and other communications are entered into the electronic medical record of each subject.
• Resolve data queries with sponsors/CROs.
• Support multicenter coordination and external collaborations, including communication with partner sites, core labs, and external stakeholders as applicable.
• Recruit, train, and supervise full-time research staff.
• Develop/help create EPIC Smart phrases.
• Develop and maintain detailed project plans and timelines; oversee recruitment and enrollment strategies; ensure adherence to study milestones.
• Track progress and proactively identify and resolve operational challenges.
• Oversee compliance reviews and ensure audit and inspection readiness across assigned studies.
• Promote consistency in processes, tools, and documentation; contribute to development and implementation of best practices and standard operating procedures.
• In collaboration with PPMC Administrative Director, obtain detailed knowledge of all components of trial protocols: screening and enrolling patients, conducting follow-up activities, abstracting medical and demographics data from medical records, completing source documents and case report forms, data entry using various electronic data collection systems, managing the adverse event reporting process.

Clinical Research Project Manager C

• Staff supervision: Assist and train direct and/or indirect research staff on procedures as required per protocol(s), including onboarding and training, data and lab management, protocol compliance and QC/QA, human subjects protection and GCP, and project assignments/staff mentoring/biannual performance appraisal completion.
• Independently manage complex, multi-site cardiovascular clinical research studies in collaboration with the Principal Investigator, including daily operations, study coordination, recruitment/enrollment oversight, and troubleshooting in accordance with GCP and all applicable regulatory requirements.
• Assist in research studies using approved protocols according to GCP; familiarize with all components of study protocols by review of study; attend Investigators Meetings.
• Assure accurate completion and updates of the Delegation of Duties and Authorized Signatures Form; confer with the pharmacist as needed to assure availability of study drug.
• Create and maintain research data and regulatory files.
• Timely initiation of screening and enrolling patients; screen to identify potential patients for specific studies, determine patient eligibility by communicating with physicians, clinical staff, and reviewing medical records to validate potential patient data against Inclusion/Exclusion checklists.
• Recruit patients, explain protocol and consent forms; assure original signed consents are maintained in the study binder.
• Complete screening/enrollment logs and submit to sponsor as protocol requires.
• Complete all source documents and worksheets; complete and/or enter all clinical record forms (CRFs); create and maintain subject binders; obtain records required to complete CRFs.
• Assure inclusion of enrollment information, research orders, and other communications are entered into the electronic medical record of each subject.
• Resolve data queries with sponsors/CROs.
• Support multicenter coordination and external collaborations, including communication with partner sites, core labs, and external stakeholders as applicable.
• Recruit, train, and supervise full-time research staff.
• Develop/help create EPIC Smart phrases.
• Take leadership role in developing study documents, managing detailed operations of projects, coordinating activities in multiple studies, quality control, and leading project strategy.
• Ensure studies/research are conducted safely and according to protocol; provide supervision to teams conducting the study/interventions; collaborate with funding agencies.
• Involve hiring, onboarding, and overseeing detailed operations of clinical research activities including recruitment, conducting research visits, data entry.
• Track progress and proactively identify and resolve operational challenges.
• Oversee compliance reviews and ensure audit and inspection readiness across assigned studies.
• Supervise and mentor research staff; provide guidance on day-to-day study operations, workload prioritization, and performance expectations.
• Promote consistency in processes, tools, and documentation; contribute to development and implementation of best practices and standard operating procedures.

Qualifications

Clinical Research Project Manager B

• Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience required.
• Master's degree and 3-5 years of experience preferred.

Clinical Research Project Manager C

• Bachelor's degree and 7-10 years of related experience or equivalent combination of education and experience required.
• Master's degree and 5-7 years of experience preferred.

Pay

Annual salary range: $75,804.00 - $106,940.00. Salary 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.

Location & Department

Philadelphia, Pennsylvania. Department: Perelman School of Medicine.