Senior Clinical Project Manager

About the role

The Senior Clinical Project Manager is responsible for the management of all aspects of clinical trial conduct at the TRIAD Center, including regulatory compliance, patient safety, data quality, and personnel management. This role involves independently managing, coordinating, and providing oversight of clinical research study conduct across multiple research studies and trials at multiple clinical sites.

The position serves in a key management and administrative role for all clinical research projects conducted at the TRIAD Center by managing the clinical research team and ensuring compliance with established protocols, study timelines, and institutional, local, and federal requirements.

The Clinical Research Project Manager supports the development of research projects, including proposal applications, scientific study design, IRB protocols, budgets, contracts, personnel recruitment, hiring, and training. They also report on expenses, progress, and effort in collaboration with the Associate Director.

The candidate will work closely with superiors and executive-level management to define strategic goals for the Center, develop and implement operational plans, and maintain relationships with the Institutional Review Board, internal and external investigators, personnel at external clinical sites, funding sponsors, vendors, and other key stakeholders.

Responsibilities

• Demonstrate working and in-depth knowledge of FDA, ICH GCP, and other regulatory compliance guidelines.
• Apply working and in-depth knowledge of federal regulations and IRB procedures.
• Manage the IRB submission process and ensure compliance with requirements.
• Exhibit excellent organizational, problem-solving, and leadership abilities.
• Utilize outstanding negotiation, communication, and interpersonal skills.
• Apply in-depth knowledge of diverse operations functions and principles (e.g., resource management, finance).
• Maintain confidentiality in all work performed.
• Acquire and maintain all required CITI training certificates.
• Acquire and maintain credentialing at all required institutions, including Tulane Medical Center, University Medical Center, Touro Infirmary, and East Jefferson Hospital.
• Demonstrate a proven track record of successful clinical trial management, including overseeing studies completed on time, within budget, and to the satisfaction of stakeholders.

Requirements

• Bachelor’s degree (required).
• At least three (3) years of management experience (required).

Qualifications

• Master’s, Ph.D., or M.D. (preferred).
• 5+ years of experience managing and training clinical research staff (preferred).
• 5+ years of experience conducting cardiovascular research studies (preferred).
• Certification as a Certified Clinical Research Coordinator (CCRC through ACRP) or Certified Clinical Research Professional (CCRP through SoCRA) is strongly desired.
• Regulatory Affairs Certification (RAC), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or Certified IRB Professional (CIP) (preferred).
• Proven ability to plan and manage operational processes for maximum efficiency and productivity.
• Outstanding organizational, negotiation, communication, leadership, and interpersonal skills demonstrated by previous professional success.
• Proven ability to develop innovative solutions for increased productivity.