Clinical Trial Project Manager
3 weeks ago
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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