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HD InsightsForging a Network: Project Manager

Project management is a core function within the clinical trial, with the responsibility of ensuring it is conducted consistently, on time, within budget, and in compliance with regulatory requirements. The Project Manager (PM) is responsible for observing the conduct and progress of a clinical study in accordance with FDA requirements, among other regulatory body requirements. 

Responsibilities of a Project Manager

  • Serve as the expert in site management, study operations, regulatory requirements.
  • Institute the CRO’s (in this case HSG’s) centralized approach to project management to ensure successful study conduct.
  • Ensure all aspects of the trial are executed with the highest level of quality and integrity.
  • Work closely with study teams and leadership to provide guidance and support throughout the trial.
  • Provide direct training and assistance to sites with any issues that may arise, including with recruitment and enrollment (i.e., site staff and project team training).
  • Create study-specific timelines and reviews for weekly operations team meetings.
  • Maintain and track regulatory documents for the trial master file, coordinate central Institutional Review Board (IRB) submissions; review all informed consent forms prior to submission; track, report, and reconcile serious adverse events; and activate and train site staff.
  • Attend operations meetings and manage weekly team meetings and other meetings, as required.
  • Oversee site monitoring activities in conjunction with the sponsor.
  • Help develop a risk-based quality monitoring plan and suggested metrics for centralized assessment of data quality, site performance and protocol compliance.

Site Management

The PMs at HSG maintain close contact with each site throughout the study to proactively follow their performance and address any questions or concerns, and to provide logistical and day-to-day site support. We maintain continuous personal contact by phone, email and conference calls, ensuring effective working relationships between PMs and site study teams.

A Centralized Approach to Meet Study Timelines and Ensure Quality Results

Our centralized project management approach using HSG credentialed sites is one of our unique strengths and has been instrumental in our success conducting trials in Huntington’s disease. This approach provides many benefits, most notably having the PM as the central point of contact for all project activities. This ensures all protocol and study questions flow from the sites and vendors through the PMs for consistent responses, enabling us to track trends and issues and address them proactively.

Sites are each assigned a Site Project Manager who is charged with consistently providing accurate and timely responses to the lead (trial) PM’s questions on routine issues in real time. The lead PM may sometimes escalate issues, concerns, or non-routine questions to study leaders, including the Study Principal Investigator (SPI), who typically addresses the issues with site PM directly. In HSG trials, SPIs are involved at all levels of the trial.

Participant Recruitment, Enrollment and Retention

HSG Project Managers utilize established methods and experience to recruit, enroll, and retain participants in HD trials. We leverage our unique relationships with the HD community for rapid access to patients, families, and HD advocacy groups worldwide and maximize our relationships with HSG participating and non-participating sites to assist with effective recruitment.

Our outreach tools include robust social media and marketing programs that are specially tailored for the HD population. We also utilize a unique study-specific recruitment reservation process that helps the study team track potential participants during prescreening, screening and enrollment, in real time.

HSG’s experience in HD, a rare and orphan disease research environment, has enabled us to develop recruitment and retention strategies customized to the unique needs of HD sites, patients, families, and the sponsor’s trial. Our experience indicates that in HD research, trial recruitment, enrollment and retention must not only focus on the potential participant but have roots in an understanding of their family support system.

In fact, most potential participants for the trials are known by the site staff. The Site Investigator and Site Coordinator may already be engaged with the patients and families and many sites have a database of people who have expressed interest in participating in future clinical research.

The Ladder to Project Manager

Someone aspiring to be a Project Manager is best served by having assumed coordinator roles within a clinical trial or having extensive clinical coordinator experience to provide knowledgeable study oversight. Administrative and organizational skills and a facility with project planning software are also needed. The PM must also have the ability to see the whole picture, how each role is successfully fulfilled and when each trial team member’s role comes to the forefront.

Keeping the sites on track can require patience, perseverance and resourcefulness, and is helped by building longstanding relationships in the HD community. Being someone who sees challenges as part of the process, who is a resourceful “fixer” by nature, instead of reacting rigidly to problems, is important as you work with the team to bring the trial to successful completion. Finally, being a supportive, positive, accessible resource to everyone involved goes a long way!