Clinical Trials Project Manager

1 week ago

Frederick, Maryland, United States Cartesian Therapeutics Full time

Job Overview

Clinical Trials Manager at Cartesian Therapeutics - a company reimagining cell therapies to bring new treatment options to patients with autoimmune diseases.

About Us

We are seeking a highly skilled and experienced Clinical Trial Manager (CTM) to lead the execution and coordination of activities related to initiating, managing, and completing clinical trials in accordance with Company SOPs, ICH/GCP regulations, and study-specific manuals and procedures.

The Role

This role requires meticulous attention to detail, excellent communication skills, and the ability to work effectively within a multidisciplinary team environment. As a Clinical Trials Manager, you will be responsible for managing essential duties and responsibilities independently as possible, with guidance and oversight provided by the Head of Clinical Operations when needed.

Key Responsibilities

  • Maintain accurate and up-to-date site, vendor, and internal study team contact information
  • Assist with study start-up of clinical trials, including feasibility, investigator recruitment, collection of regulatory documents, and general site management support
  • Communicate directly with sites to drive collection of essential documents from start-up through study closure
  • In collaboration with the study team, identify risks to study and assist in developing 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, including but not limited to training materials, plans, operating manuals, presentations, and reports
  • Support the study team in creating and implementing study-specific tools to ensure clean data and timely data entry and may assist in clinical data review and resolution of queries as needed
  • Participate in and manage study team meetings and meetings with CROs, vendors, and multi-functional teams and prepare meeting agendas, minutes, and track action items
  • Manage performance of field CRAs, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Management
  • Assist with CRA and third-party vendor training on protocols and practices
  • Maintain study tracking, including regulatory Q&A, site start-up regulatory timeline, protocol issue tracker, and other study tracking as appropriate
  • In collaboration with the CRO and the 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 the site budgets and the review of clinical site invoices, in collaboration with the study lead(s) and/or VP, Clinical Operations or designee
  • Track and report on progress of study, including but not limited to site activation, patient enrollment, monitoring visits
  • Lead or participate in functional initiatives and/or activities as assigned.

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

Salary Information

The estimated salary range for this position is $125,000 to $150,000 per year, based on industry standards and relevant factors such as experience, education, and specific skills. We believe in rewarding our team members fairly and encourage open discussions about compensation throughout the hiring process.

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