Brooke Compton Email & Phone Number

Dublin, Ie

Project Director in Real World research with emphasis on post-marketing research and qualified minimal risk studies. Broad experience in late phase study designs including decentralized clinical trials (DCT), expanded access, and extended rollover programs. Responsible for the overall direction, coordination, implementation, execution, control and completion of projects ensuring consistency with company strategy, commitments and goals. Responsible for providing project management leadership to cross-functional teams and managing projects to ensure integration, coordination and consistency of processes throughout project life-cycle.

Dublin, Ie

Project Manager in Real World research with emphasis on post-marketing research and qualified minimal risk studies. Broad experience in late phase study designs including decentralized clinical trials (DCT), expanded access, and extended rollover programs. Responsibilities include primary liaison with the client and oversight of cross functional project team

Dublin, Ie

Project Manager in Real World research with emphasis on post-marketing research and qualified minimal risk studies. Broad experience in late phase study designs including decentralized clinical trials (DCT), expanded access, and extended rollover programs. Responsibilities include primary liaison with the client and oversight of cross functional project team

Practical, hands-on operational support for eTMF3 including: disseminating tips and tricks to colleagues, demonstrating best practices in local meetings, provide role-based system support, present system updates to local teams, act as a resource for practical questions related to eTMF3, identify and escalate gaps in training/learning, and be a conduit for local teams to present ideas for improvement.

Proactively strengthen areas in PRA Clinical Operations' utilization of and training on CTMS in support of better data quality and integrity, proper implementation of PRA processes and business rules, and achievement of corporate key performance indicator objectives.

Operational Study Manager in Real World research with emphasis on post-marketing research and qualified minimal risk studies. Broad experience in late phase study designs including expanded access programs. Responsibilities include oversight of operational team and management of study sites from recruitment through study closure.

Accountabilities include: lead, manage, and motivate the clinical team; create and maintain all relevant clinical project documents and tools pertinent to the study; provide project oversight and leadership for clinical deliverables; ensure compliance with company, applicable regulatory, and customer requirements; serve as the primary liaison and point of escalation for clinical activities and team issues, interacting with clients, vendors and other functional areas.

Therapeutic experience includes oncology (4 years) and neurology (1 year). Accountabilities include: perform on-site and remote monitoring visits; ensure ICH-GCP, FDA, and protocol compliance; protect subject rights and safety; build and maintain site relationships from study start-up through close-out.

Manage global project teams throughout the migration process to ensure successful eTMF migration and delivery of a complete and quality trial master file. Provide training and guidance for the migrating project teams on the migration process.Ensure compliance to the migration process and timely completion of all migration related activities. Support the migrating project teams on the migration process throughout all steps/phases. Review and follow-up on migration deviation report. Review and sign-off on migration summary report.

Evaluate and enhance all trip report (PSSV, SIV, IMV, and COV) questions and annotations to drive value by eliminating repetitive questions, add/modify questions, leverage the parent/child question feature, and adjust the flow of sections within each trip report.

Master'S Degree, Master Of Science In Managment

Bachelor'S Degree, Bachelor Of Arts In Human Biology