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Clinical Trial Project Leader

2 months ago

Boston, Massachusetts, United States Mass General Brigham Full time

Position Overview

The Cardiac Imaging Core Lab (CICL) operates as a prominent academic research entity affiliated with a leading healthcare institution. Our focus is on delivering echocardiography core laboratory services for extensive global clinical trials, which involves site training, interface management, and quantitative analysis of received imaging data. The CICL collaborates closely with sponsors, contract research organizations (CROs), and clinical trial sites that submit echocardiograms directly to our lab. Our dedicated team of approximately 40 professionals supports over 40 active clinical trials, processing a typical volume of 1000 to 1500 echocardiograms monthly.

Key Responsibilities

Project Management

  • Maintain meticulous organization of each assigned trial's progress, ensuring attention to detail in tracking received media, managing inventory, and following up on pending tasks while monitoring project timelines and reporting metrics to stakeholders.
  • Engage in decision-making processes related to CICL that influence study outcomes.
  • Facilitate efficient daily operations for multiple studies, acting as the primary contact for sponsors, CROs, and CICL leadership regarding ongoing issues and progress updates.
  • Represent the CICL at investigator meetings and training sessions, which includes developing training materials, tracking attendance, and presenting relevant data.
  • Oversee all study documentation, ensuring compliance with established document control standards.
  • Process incoming subject and study documents for accuracy, addressing technical issues related to image files, including necessary repairs and compliance with privacy protocols.
  • Coordinate technical feedback distribution to sites, ensuring effective communication regarding sonographer certification and quality assessments.
  • Assist technical teams in prioritizing timelines to meet data transfer deadlines.
  • Compile study metrics for invoicing and other reporting requirements.
  • Support sites with inquiries regarding study protocols and image submission processes.
  • Lead on-site monitoring and auditing activities, managing vendor qualification documentation.

Information Systems

  • Collaborate with CICL staff and information systems personnel to address technical issues related to computer systems, data security, and software improvements.

Data Management

  • Work with CICL staff to create and manage databases, ensuring accurate data handling and reporting.
  • Generate both study-specific and cumulative progress reports for stakeholders.
  • Coordinate with study sponsors and data centers to facilitate proper data management and transfers.

General Responsibilities

  • Support the implementation and enhancement of CICL policies and procedures, monitoring adherence and effectiveness.
  • Provide additional support as directed by CICL leadership in relation to research initiatives.
  • Participate in operational meetings, delivering necessary updates on assigned studies.
  • Offer backup support for the CICL operational team as required.
  • Perform other duties as assigned.

Qualifications

  • Bachelor's degree in biological sciences or health administration.
  • A minimum of 5 years of experience in clinical research or project management.
  • Familiarity with FDA regulations, ICH, and GCP guidelines related to human subject research, particularly concerning data security and compliance.

Skills and Competencies

  • Highly organized with a systematic approach to work.
  • Self-motivated and proactive, capable of identifying and resolving issues independently.
  • Able to thrive in a dynamic and fast-paced environment.
  • Skilled in building strong relationships with diverse stakeholders.
  • Dependable with a focus on data quality and integrity.
  • Effective communicator, both verbally and in writing.
  • Passionate about clinical research, particularly in cardiovascular medicine.

Supervisory Responsibilities

No direct supervisory responsibilities, but will oversee the work of Clinical Trial Coordinators assigned to each study.

Working Conditions

This position supports a hybrid work model, requiring in-office collaboration with team members for a minimum of three days per week during standard business hours.