Clinical Trials Unit Project Manager 1, 2, or 3

Louisiana State University; Baton Rouge, Northern (LA, KY); Hybrid; USD 95,000 - 130,000; Full time

Job summary

Pennington Biomedical Research Center, part of Louisiana State University, is seeking a Project Manager to coordinate clinical trials and manage day-to-day operations in the Clinical Trials Unit. You will oversee timelines, regulatory tasks, participant recruitment, and data collection, while ensuring GCP compliance and collaboration with investigators.

The role demands strong project management, stakeholder communication, and the ability to lead multidisciplinary teams to deliver study

Qualifications

• 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.
• Working knowledge of Good Clinical Practice (GCP), clinical research regulations, and institutional requirements.

Responsibilities

• Coordinate planning, implementation, and day-to-day operations of assigned clinical trials, including timelines and milestones.
• Coordinate regulatory and study start-up activities, including preparation and submission of regulatory documents.
• Manage study activities across the research lifecycle: recruitment, enrollment, visits, data collection, and closeout.
• Monitor progress, milestones, and KPIs; identify barriers and resolve issues.
• Collaborate with investigators and leadership to develop study plans, protocols, and recruitment strategies.
• Promote collaboration and accountability across multidisciplinary clinical research teams.

Skills

Project coordination

Stakeholder communication

GCP knowledge

Multidisciplinary teamwork

Project management

Education

Bachelor's degree in clinical research, health sciences, life sciences, public health, nursing, healthcare administration, business, or related field

Job description

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 related field, including at least four years of project or clinical trial management experience.* Demonstrated experience independently managing complex clinical trials or multiple concurrent research projects from study start-up through closeout.* Advanced knowledge and demonstrated application of Good Clinical Practice (GCP), clinical research regulations, and institutional requirements.* Demonstrated experience leading multidisciplinary project teams, managing complex timelines and competing priorities, resolving operational issues, and coordinating with investigators and internal and external stakeholders.*Pennington Biomedical Research Center seeks to recruit a highly productive workforce with a broad range of backgrounds and perspectives and will provide equal employment opportunities to all employees and prospective employees. Employment decisions shall be based strictly on merit and without regard to religious or political beliefs, sex, race, or any other non-merit factor.*## Additional Job Description:## Competencies:None## Special Instructions:Interested candidates should include a resume and a list of three (3) professional references to the online application. Professional references should be the name, title, company, and contact information from past employers. Professional references should include current or previous supervisors and/or coworkers. Personal references should not be considered for the reference check process. We will respect the request that we do not contact a current employer. However, we will need to contact a prior supervisor if such a request is made. A letter of application/cover letter is recommended but not required. Official transcripts are required prior to hire and are not required at the time of application.