What are the responsibilities and job description for the Clinical Trial Assistant Project Manager position at Vitalief?
About Vitalief
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.
The Role
Vitalief is seeking a highly organized and detail-oriented Assistant Project Manager to provide operational oversight and coordination for our client’s Pediatric Acute Leukemia clinical trials. This full-time, fully benefited role serves as the primary liaison between the pharmaceutical clinical research team and CROs, ensuring trials are executed efficiently, on budget, and in compliance with regulatory standards. The Assistant Project Manager bridges scientific and operational aspects of clinical research, leading cross-functional teams to deliver high-quality studies evaluating the safety and efficacy of pharmaceuticals.
WHY VITALIEF?
- Contribute to advancing scientific discoveries that improve patient lives.
- PEOPLE FIRST culture with opportunities for growth and innovation.
- Competitive benefits include 20 PTO days 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans.
- Salary Range: $70,000 to $85,000 (commensurate with experience).
- Work Location: 100% Remote (seeking only candidates that live in the EST Zone).
KEY RESPONSIBILITIES
Trial Planning and Initiation
- 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.
QUALIFICATIONS
Education and Experience
- 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.
- 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.
PHYSICAL DEMANDS: Prolonged periods sitting working on a computer, standing, walking, visual perception, talking and hearing. Lifting up to 20lbs.
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Salary : $70,000 - $85,000