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Vitalief Inc. · 3 months ago

Clinical Research Study Manager

Newark, NJ

Full-time

Onsite

Mid, Senior Level

3+ years exp

Vitalief Inc. partners with various organizations to enhance research operations and improve patient care. The Clinical Research Study Manager will oversee multiple NIH-funded observational studies on tuberculosis, ensuring effective communication between U.S. and international teams while managing operational challenges and compliance with regulatory standards.

AdviceClinical TrialsHealth Care

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

Qualification

Clinical research managementInfectious diseases experienceProject managementCross-cultural communicationNIH regulatory knowledgeMicrosoft Office proficiencyREDCap experiencePeople managementOrganizational skillsProblem-solving skillsAdaptability

Required

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

Ability and willingness to travel internationally up to 30% of the time

Preferred

Familiarity with NIH-funded research and related regulatory requirements preferred

Proficient in Microsoft Word, Excel, Access, and PowerPoint; experience with REDCap is a plus

Benefits

20 PTO days + 9 paid holidays

Company-paid life insurance and short/long-term disability

401(k) retirement program

Comprehensive healthcare plans

Company

Vitalief Inc.

We recruit top talent from across the clinical research industry to support our clients in planning and execution of successful clinical trials with the goal of having a positive impact on people’s lives.

Founded in 2021

New Brunswick, New Jersey, USA

51-200 employees