Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
Under the leadership of the PI of the MPN-RC and PI of Project 4 (clinical trials) and in collaboration with the Clinical Trials Manager, the Project Manager I will provide regulatory expertise for multi-center clinical trial(s) with 11 clinical sites across the US and in Canada to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management, in accordance with the appropriate quality standards including ICH/GCP and applicable global regulations. The project manager will be available to external site investigators and regulatory staff to assist with the implementation and management of the MPN-RC studies at each site. S/he supports department leadership, organizes conferences, seminars, location moves, educational initiatives and other projects, and is responsible for the creation and monitoring of timelines and other specifications.
- Ensure all regulatory requirements, study timeframes and targets are met for assigned project(s).
- Contribute to protocol development, including organizing, formatting, and editing
- Ensure regulatory and safety compliance throughout trial by supporting preparation and submission of expedited and aggregate reports (e.g DSURs) to regulatory authorities
- Reviews serious adverse event (SAE) reports from clinical trials to ensure accuracy, integrity and completeness of safety information
- Work with sites and data monitor to track safety data and maintain consistency of safety assessments
- Set up, organize, track and maintain clinical study and project documentation both hardcopy and electronic (e.g. Main Study Files, CRFs, etc.) including document receipt and review, scanning and indexing, quality control, copying, filing, preparation for internal/external audits, final reconciliation and archival at MSSM
- Provide project document management support to cross-functional teams by assisting in the administration, archive and tracking of essential documents of assigned projects
- Assist in quality control audits of clinical study and project documentation (e.g. Main/Central Study Files, Monitoring Files, etc. at MSSM
- Assists with the development and maintenance of study specific manuals, SOPs, monitoring plan and study specific documents
- Participates in the preparation of FDA IND initial filing, annual filing, and submitting amendments to the FDA
- Ensures study adherence to ICH/GCP and SOPs and International guidelines by conducting reviews of labels, literature and web sites for accuracy, consistency and regulatory compliance
- Participate in project meetings and investigator conference calls
- Other special projects as deemed necessary.
- BA/BS degree in Life Sciences discipline required. RN, BSN in nursing preferred, or combination of equivalent experience and education.
- CCRA or CCRC Certification from ACRP or SOCRA recommended
- Five years regulatory experience or managing operational aspects of a clinical study, preferably in oncology
- Proven clinical development experience, including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock
- Excellent computer skills and data management skills
- Demonstrated ability to work collaboratively with others
- Well developed written and verbal communication skills demonstrated by the ability to present clear instructions
- Experience with the preparation of reports and/or presentations/communications via tools such as PowerPoint
Skills & Abilities:
- Microsoft Word, PowerPoint, Excel
- Microsoft Outlook
- Electronic Data Capture Experience Necessary