Clinical Trials Unit Project Manager

Pennington Biomedical Research Center, a world-renowned academic research institute of Louisiana State University, is seeking a Project Manager in the Clinical Trials Unit.
*** Major Responsibilities
**** Coordinate the planning, implementation, and day-to-day operations of assigned clinical trials, including timelines, milestones, priorities, workflows, and study deliverables.
* Coordinate regulatory and study start-up activities, including preparation and submission of required regulatory documents, study materials, amendments, and continuing reviews.
* Manage study activities throughout the research lifecycle, including participant recruitment and screening, enrollment, study visits, follow-up, data and document collection, and study closeout.
* Coordinate and monitor project team activities to ensure compliance with study protocols, Good Clinical Practice (GCP), applicable regulations, institutional policies, and sponsor requirements.
* Collaborate with Principal Investigators and study leadership to develop and implement study plans, protocols, training plans, recruitment strategies, inclusion/exclusion criteria, and participant targets.
* Monitor study progress, recruitment, enrollment, participant retention, regulatory milestones, and other key performance indicators; identify barriers and facilitate timely resolution of issues.
* Coordinate communication among Principal Investigators, research staff, sponsors, monitors, regulatory personnel, clinical partners, and other stakeholders.
* Maintain accurate and timely study documentation, records, data, and tracking systems in accordance with protocol, regulatory, institutional, and sponsor requirements.
* Coordinate study team meetings, training, and orientation activities and provide guidance to project team members regarding study procedures, protocols, and research requirements.
* Identify and implement opportunities to improve clinical research processes, workflows, communication, and study operations.
* Promote collaboration, accountability, and effective teamwork across multidisciplinary clinical research teams.
* Perform other duties related to clinical research operations as assigned.

* As part of a career progression group, this vacancy may be filled as a Project Manager 1, 2, or 3 depending on the level of experience of the selected applicant.  
*** Complexity differences:***
* ** Project Manager 1:
** Coordinates assigned studies with established procedures and guidance; manages routine/less complex projects.
* ** Project Manager 2:
** Independently manages moderately complex studies and projects; exercises greater judgment and coordination responsibility.
* ** Project Manager 3:
** Leads complex, high-impact, or multiple studies/projects; provides advanced project leadership, resolves complex operational issues, and may have significant responsibility for staff, sponsors, budgets, or study portfolios.  
*** Required Qualifications
***** Project Manager 1
*** Bachelor's degree in clinical research, health sciences, life sciences, public health, nursing, healthcare administration, business, or a related field.
* Two years of experience in clinical research, clinical trial coordination, healthcare research, or a related field.
* Experience coordinating research projects, clinical studies, or multidisciplinary activities.
* Working knowledge of Good Clinical Practice (GCP), clinical research regulations, and applicable institutional requirements.  
** Project Manager 2
*** Bachelor's degree in clinical research, health sciences, life sciences, public health, nursing, healthcare administration, business, or a related field.
* Four years of experience in clinical research, clinical trial coordination, healthcare research, or a related field, including at least two years of project or clinical trial management experience.
* Demonstrated experience independently coordinating clinical trials or research projects from study start-up through closeout.
* Demonstrated knowledge and application of Good Clinical Practice (GCP), clinical research regulations, and institutional requirements.
* Experience coordinating multidisciplinary project teams and managing competing priorities, timelines, and study deliverables.  
** Project Manager 3
*** Bachelor's degree in clinical research, health sciences, life sciences, public health, nursing, healthcare administration, business, or a related field.
* Six years of experience in clinical research, clinical trial coordination, healthcare research, or a…