Clinical Research Project Manager B/C

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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
• The Project Manager B will provide advanced project management and operational expertise in support of clinical research studies conducted within the Cardiovascular Division of PPMC. PM B position provides independent oversight of study operations, including project planning, team management, and study execution.

The Project Manager B will serve as the primary project manager for assigned studies, with accountability for study execution, operational planning, and overall performance including enrollment. This role will coordinate complex study activities across multidisciplinary teams including investigators, coordinators, core labs, and external collaborators. The Project Manager B will ensure studies are conducted in accordance with protocol requirements, sponsor expectations, and all applicable regulatory and institutional guidelines.

Responsible for assisting with study coordination and recruitment for industry sponsored studies. Works directly with study physicians, research director and other research staff. Performs screening visits, consenting of participants, entering data into databases. Coordinate several investigational trials within the cardiovascular division of PPMC, instruct and support investigators and study staff on carrying out clinical protocol and other study related requirements

• Responsibilities include developing and maintaining detailed project plans and timelines, overseeing recruitment and enrollment strategies, and ensuring adherence to study milestones. PM B will lead track progress and proactively identify and resolve operational challenges. This individual will oversee compliance reviews and will ensure audit and inspection readiness across assigned studies. PM B will supervise and mentor research staff, and will provide guidance on day-to-day study operations, workload prioritization, and performance expectations. This role will promote consistency in processes, tools, and documentation, and contribute to the development and implementation of best practices and standard operating procedures. In collaboration with PPMC Administrative Director, the Project Manager B will 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.
• The Project Manager B functions with a high degree of independence in managing assigned projects but escalates strategic decisions and high-level study direction to senior leadership (e.g., Administrative Director, etc.).

• Clinical Research Project Manager C
• The Project Manager C will support the PPMC Cardiovascular Research and be responsible for day-to-day operations of multiple clinical research projects. The Research Project Manager will take leadership role in developing study documents managing the detailed operations of projects, coordinating activities in multiple studies, quality control and will lead project strategy. PM C will be required to ensure that studies/research are conducted safely and according to protocol, provide supervision to the teams conducting the study/interventions and collaborates with the funding agencies..

The Project Manager C will serve as the primary project manager for assigned studies, with accountability for study execution, operational planning, and overall performance including enrollment. This role will coordinate complex study activities across multidisciplinary teams including investigators, coordinators, core labs, and external collaborators.

This is a leadership position and will involve hiring, onboarding and oversee the detailed operations of clinical research activities including recruitment, conducting research visits, data entry. Coordinate investigational trials within the cardiovascular division of PPMC, instruct and support investigators and study staff on carrying out clinical protocol and other study related requirements

PM C will lead track progress and proactively identify and resolve operational challenges. This individual will oversee compliance reviews and will ensure audit and inspection readiness across assigned studies. PM C will supervise and mentor research staff, and will provide guidance on day-to-day study operations, workload prioritization, and performance expectations. This role will promote consistency in processes, tools, and documentation, and contribute to the development and implementation of best practices and standard operating procedures.

The Project Manager C functions with a high degree of independence in managing assigned projects but escalates strategic decisions and high-level study direction to senior leadership (e.g., Administrative Director, etc.).

Job Description

This position is contingent upon favorable funding.

Clinical Research Project Manager B

Job Responsibilities

• •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 the availability of study drug. Create, maintain research data, regulatory files.
• •Timely initiation of screening, enrolling patients. Screen to identify potential patients for specific studies, determine patient eligibility by communicating with physicians, clinical staff and by reviewing medical records to validate potential patient data against Inclusion /Exclusion checklists. Recruit patients, explain protocol, consent forms. Assure original signed consents are maintained in the study binder. Complete screening/enrollment logs and submit to sponsor, as pr