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Vitalief Inc. · 2 months ago

Clinical Trial Assistant Project Manager

United States

Full-time

Onsite

Mid, Senior Level

$70K/yr - $85K/yr

5+ years exp

Vitalief Inc. partners with Sites, Sponsors, and CROs to enhance research operations and improve patient care. The Assistant Project Manager will oversee and coordinate Pediatric Acute Leukemia clinical trials, ensuring compliance with regulatory standards and efficient execution of studies.

AdviceClinical TrialsHealth Care

Responsibilities

Support bid strategies and contract discussions with CROs, including site selection and patient enrollment

Review and finalize trial protocols and related documents

Build project plans, timelines, and vendor assessments

Establish and maintain collaborative relationships with sponsors, CROs, vendors, investigators, and site staff

Monitor study activities for compliance with protocols and regulatory requirements

Identify potential delays or out-of-scope work and implement mitigations

Manage study risks and escalate issues to leadership as needed

Oversee study documentation, including case report forms, drug records, and regulatory filings

Motivate team members and investigators to achieve trial objectives

Maintain regular communication with sponsors and internal teams

Conduct status meetings and provide updates to leadership and stakeholders

Develop realistic budgets and timelines

Ensure audit readiness and compliance with ICH/GCP, FDA, IRB/IEC, and SOP requirements

Review monitoring reports and support development of study materials, processes, and committees

Anticipate and mitigate project risks

Qualification

Clinical research experienceProject management certificationOncology experienceClinical trial practicesOrganizational skillsLeadership skillsCommunication skillsInterpersonal skillsProblem-solving abilitiesDecision-making abilities

Required

Bachelor's degree in life sciences, nursing, pharmacy, medical sciences, or related field preferred

5 or more years of clinical research experience, including oversight of multicenter or complex studies; oncology experience highly preferred

2 or more years of clinical trials project coordinator and/or project manager experience, ideally working for a sponsor or a CRO

Knowledge of clinical trial practices and project management principles

Strong organizational, communication, and interpersonal skills

Ability to manage multiple projects, deadlines, and budgets effectively

Proven leadership and collaboration skills in multi-level team settings

Problem-solving and decision-making abilities in fast-paced, dynamic environments

Preferred

Bachelor's degree in life sciences, nursing, pharmacy, medical sciences, or related field preferred

5 or more years of clinical research experience, including oversight of multicenter or complex studies; oncology experience highly preferred

2 or more years of clinical trials project coordinator and/or project manager experience, ideally working for a sponsor or a CRO

Project management certification (CCPM or PMP) preferred

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