Clinical Trial Project Manager

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Boston, United States Medasource Full time

Job Responsibilities:

Project Management:

  • On a daily basis, provides clear and consistent organization of each assigned trial’s status with strong attention to detail; this includes hands-on tasks such as tracking media received, inventory control, ensuring proper follow-up of pending project tasks, monitoring project timelines and associated reporting of study-specific metrics to sponsors/CROs.
  • Participates in all CICL related decisions made for the study.
  • Ensure smooth and efficient internal day-to-day operations for numerous assigned studies. This will include serving as the primary liaison with Sponsor/CRO and CICL leadership for day-to-day issues, progress reporting, and attending study specific meetings.
  • Represent the CICL as site Investigator Meetings and imaging-centered training sessions for site staff. Includes both development of training materials, tracking attendance, and presenting data about the CICL and applicable study.
  • Responsible for the oversight of all study files.
  • Maintain appropriate document control standards per MGB and CICL SOPs.
  • Processing incoming patient/study documents and images for accuracy and completeness.
  • Includes troubleshooting technical issues pertaining to images received including repairing image files and removing PHI from images and following associate PHI breach protocols.
  • Providing site feedback for sonographer certification, eligibility confirmation and quality feedback. Includes working with sites to distribute and resolve CICL-generated queries.
  • Assist technical teams with prioritizing timelines by creating project analysis lists and schedules
  • Reporting study metrics to Business Manager for invoicing purposes and other reporting as requested.
  • Directly support site representatives with questions regarding study protocol, queries, and the image submission process. Respond and field questions submitted to the CICL site line and helpdesk email.
  • Coordinate and monitor ongoing reproducibility assessments as a part of new hire training.

Information Systems:

  • Serve as a liaison between CICL and MGB Information Systems/Information Security personnel for issues as they pertain to CICL computer systems, data
  • security, software development, infrastructure improvement, quality improvement, and workstation issues.
  • Serve as a liaison between external vendors for CICL software and analysis programs, including troubleshooting, software upgrades, and new software procurement.
  • Support technical staff with software and workstation updates to ensure optimal workflow
  • Assist with database and software validation.
  • Provide and monitor access to CICL secure file shares. Assist staff with mapping file shares.

Data Management:

  • Creation of new, and management of existing CICL databases.
  • Responsible for generating both study-specific progress reports and data as well as generating center-wide cumulative data and progress reports.
  • Work with Study Sponsors and/or Data Coordinating Centers along with the CICL Clinical Data
  • Coordinator to ensure proper data management, including data transfers of final data to study Sponsors.

General:

  • Facilitate the implementation and ongoing process improvement of established CICL Policies and Procedures; responsible for monitoring the effectiveness and adherence to policies, generation of new policies, prn.
  • Provide other support as per the CICL Directors as it relates to the overall research scope of the CICL.
  • Train and assist with onboarding CICL Operational and Technical Team members.
  • Attend CICL Operational and Team meetings, providing necessary updates.
  • Provide back-up coverage for CICL Operational Team as needed.

Minimum Qualifications:

  • BA/BS degree in biological sciences or health administration.
  • Research professional with at least 5 years’ experience in clinical research and/or trial project management.
  • Knowledge of FDA regulations, ICH and GCP guidelines concerning human subject research especially as they relate to computer systems/security, disaster recovery and regulatory compliance of research core labs.
  • highly organized and systematic in work processes
  • self-motivated and proactive; able to identify, track, and drive issue resolution with little or no supervision or prompting
  • able to function at a high level in a dynamic and busy environment
  • able to take direction from, as well as influence and establish strong working relationships with a wide variety of individuals at all levels; ie. other Center project staff, technical staff, Directors, enrolling sites, Sponsors and other affiliate groups
  • very dependable and able to demonstrate a respect for the importance of how work practices affect data quality
  • able to communicate concisely and effectively, without undue delays, both verbally and in writing
  • a clinical research professional, or aspires to become one, with an interest in cardiovascular medicine, human subject research and clinical trial project management.

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