Clinical Research Study Manager

Vitalief • Newark, NJ

88d

About The Position

Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. We are seeking a highly organized and detail-oriented Clinical Research Study Manager to provide operational oversight and coordination of multiple NIH-funded observational tuberculosis studies conducted at a number of international sites. This role supports U.S.-based leadership during a staffing transition and ensures smooth communication and collaboration between domestic and overseas research teams. Periodic international travel will be required to gain first-hand understanding of study operations, challenges, and systems.

Requirements

• Master’s degree in life sciences, public health, or a related field.
• Minimum of 3 years of experience managing clinical research studies, preferably in infectious diseases or global health.
• Proven success building and maintaining strong, collaborative relationships with international research sites and cross-cultural teams.
• Exceptional organizational, project management, people management, and problem-solving skills with demonstrated ability to manage multiple priorities.
• Excellent communication and interpersonal skills, with the ability to navigate collaborations across time zones and diverse cultures.
• Culturally sensitive, flexible, and resourceful in addressing challenges in global health research settings.
• Proactive, adaptable, and detail-oriented professional who thrives in complex, dynamic environments.
• Familiarity with NIH-funded research and related regulatory requirements preferred.
• Proficient in Microsoft Word, Excel, Access, and PowerPoint; experience with REDCap is a plus.
• Ability and willingness to travel internationally up to 30% of the time.

Responsibilities

• Oversee day-to-day management and coordination of multiple ongoing international observational studies in infectious diseases (tuberculosis).
• Serve as the primary liaison between U.S.-based staff (managing two coordinators) and international trial site teams, ensuring clear communication and timely issue resolution.
• Work closely with trial site PI’s, coordinators, clinicians, laboratory scientists, and U.S.-based staff to align study goals and deliverables.
• Ensure operational excellence, compliance with regulatory standards, and adherence to NIH funding requirements.
• Support transparent communication across international teams by leading team meetings to provide project updates for investigators and leadership.
• Oversee study progress, budgets, resources, and milestones; identify and resolve operational challenges.
• Support investigators and site teams in study execution, data quality assurance, and reporting consistency.
• Facilitate regular project meetings and prepare updates for investigators and senior leadership.
• Facilitate study operations, troubleshoot challenges, and ensure high-quality data collection and reporting.
• Conduct international site visits and monitoring trips as needed to assess study performance and foster collaboration across global teams.

Benefits

• 20 PTO days + 9 paid holidays
• Company-paid life insurance and short/long-term disability
• 401(k) retirement program
• Comprehensive healthcare plans
• Market-competitive salary, commensurate with experience

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Master's degree
• Number of Employees: 51-100 employees