Clinical Trial Manager

$130,000 - $142,000/Yr

EPM Scientific - Jersey City, NJ

Full-time - Mid Level

Jersey City, NJ

Administrative and Support Services

About the position

The Clinical Trial Manager will play a pivotal role in the management and execution of clinical trials, particularly focusing on a large phase 3 Oncology trial. This position is situated within a rapidly growing biotech company that is recognized for its innovative drug discovery platform and is led by a team of industry veterans from established pharmaceutical backgrounds. The Clinical Trial Manager will be responsible for overseeing all trial start-up activities, which includes collaborating with various Clinical Operations functions to ensure efficient site selection, conducting feasibility assessments, and preparing necessary study documentation. In addition to managing trial start-up activities, the Clinical Trial Manager will oversee the comprehensive in-house management of international clinical trials. This includes ensuring the delivery of high-quality study data within established timelines and budget constraints. The role requires collaboration with external vendors, such as Contract Research Organizations (CROs), central laboratories, and imaging providers, to ensure their effective contribution to the trial. The Clinical Trial Manager will also lead the creation and maintenance of all study files, including the study master file, and will conduct periodic reviews of the Sponsor Trial Master File to ensure compliance and accuracy throughout the trial process.

Responsibilities

• Handle all trial start-up activities, partnering with Clinical Operations functions to ensure efficient site selection, feasibility assessments, and preparation of study documentation.
• Oversee and guide the comprehensive in-house management of international clinical trials, ensuring the delivery of high-quality study data within established timelines and budget.
• Collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective contribution to the trial.
• Lead the creation and maintenance of all study files, including the study master file, and oversee site files while conducting periodic reviews of the Sponsor Trial Master File.

Requirements

• Four years of experience in clinical trial management.
• Five years of experience in oncology, neurology, and immunology.
• Eight years of experience in clinical trials.

Benefits

• 401k plan with company matching.
• Generous PTO, holidays, and parental leave.
• Medical (premiums 95% covered), dental, and vision (premiums 100% covered).