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Clinical Trials Manager

1 month ago

Frederick, Maryland, United States Cartesian Therapeutics Full time
Clinical Trials Manager

Cartesian Therapeutics is a pioneering company in cell therapies, aiming to bring innovative treatment options to patients with autoimmune diseases. We are seeking a highly skilled Clinical Trials Manager to lead the execution and coordination of clinical trials in the Autoimmune therapeutic area, with a focus on Cell & Gene Therapy. The ideal candidate will have a strong background in Phase I-III clinical trials and excellent communication skills to work effectively within a multidisciplinary team environment.

Key Responsibilities:
  • Maintain accurate and up-to-date site, vendor, and internal study team contact information.
  • Assist with study start-up, including feasibility, investigator recruitment, and general site management support.
  • Communicate directly with sites to drive collection of essential documents from start-up through study closure.
  • Identify risks to study and develop risk mitigation plans, including communication with management when necessary.
  • Review monitoring reports and monitoring visit letters to assess trends and site performance.
  • Initiate and/or contribute to the creation and maintenance of documents and plans for assigned clinical studies.
  • Support the study team in creating and implementing study-specific tools to ensure clean data and timely data entry.
  • Participate in and manage study team meetings and meetings with CROs, vendors, and multi-functional teams.
  • Manage performance of field CRAs, including co-monitoring, to ensure compliance with study protocol and scope of work.
  • Assist with CRA and third-party vendor training on protocols and practices.
  • Maintain study tracking, including regulatory Q&A, site start-up regulatory timeline, and protocol issue tracker.
  • In collaboration with the CRO and study lead(s), establish and maintain the Trial Master File in inspection-ready state.
  • Perform and support QC reviews of study, country, and site files, including issue resolution.
  • May conduct Pre-Study Visits and Site Initiation Visits.
  • Support preparing submissions and obtaining approval from local Health Authorities and Ethics Committees.
  • Assist with Investigational Product inventory, tracking, and shipping to clinical sites and reconciliation.
  • Support the negotiations and management of site budgets and review of clinical site invoices.
  • Track and report on progress of study, including site activation, patient enrollment, and monitoring visits.
Requirements and Desired Experience:
  • Bachelor's degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred.
  • Minimum of 4 years of experience as a Clinical Trial Manager, with significant experience in Phase I-III clinical trials within the Autoimmune therapeutic area.
  • Demonstrated expertise in Cell & Gene Therapy trials is highly desired.
  • Strong understanding of GCP, FDA, and ICH guidelines, regulations, and compliance requirements.
  • Proven ability to manage multiple tasks, prioritize workload effectively, and meet deadlines in a fast-paced environment.
  • Excellent interpersonal, communication, and organizational skills.
  • Ability to travel domestically and internationally, as required, up to 50%.
  • Certification as a Clinical Research Professional (CCRP) or equivalent is a plus.
  • Proficiency in Microsoft Office Suite and familiarity with electronic data capture (EDC) systems.