Summary

We are looking for a Senior Clinical Trial Manager for a biotech client, based out of Waltham, MA. The Sr CTM is responsible for assisting in the execution and oversight of clinical trials in autoimmune disease. This position reports to the Associate Director of Clinical Operations. The ideal candidate will have the minimum of a B.S. degree in science or healthcare and have at least seven years of clinical research experience, preferably in early phase development. This is a hybrid role based in Waltham, Massachusetts.

Responsibilities

• Oversight, management and monitoring of clinical trials from Phase I-III
• Working with cross functional teams, including regulatory affairs, QA and biostats.
• Development of study related documents, including study plans, ICF, pharmacy manuals and ensuring adherence to company policies and GCP.
• Ensure appropriate management of clinical data in a timely manner.
• Oversight of TMFs and internal file management systems.
• Assist with development and management of budgets, timelines and regulatory preparations.
• Management and assisting in selection of vendors and CROs.

Requirements

• Science or healthcare bachelor’s degree required.
• Minimum of 4 years experience working in a clinical environment, with a preference of minimum a year in a CTM or equivalent position
• Background in working with/for CROs.
• Experience in working on autoimmune clinical trials.
• Requires domestic and international travel up to 30% of time.

This is an extremely exciting opportunity to work with a stable, research focused company that specializes in early phase trials. If you are looking for your next step in the clinical industry, apply below!