Clinical Project Manager - East Coast US - Gene Therapy

Northreach - USA - My client, a pioneer in the Gene Therapy field is currently looking for an experienced Clinical Project Manager to join it's already established team to help drive Study activities for the Genotyping department: Essential Responsibilities: Responsible for the oversight and day-to-day management of genotyping activities with a specific focus on the major study study e.g. milestones, deliverables and timelines Ensure that the planning, implementation, coordination and reporting of genotyping initiatives are in line with the corporate objectives Work across all interventional trials to ensure that Study team members are able to represent the needs of the Genotyping team and objectives to respective study sites, Investigators and referral networks Support and monitor CRO and third-party vendor activities, including Investigator contract/budgets, document management, study set-up, project management Prepare and/or review Study Plans Monitor progress of studies, identify study-related trends/issues and work with the Clinical Operations/genotyping team to implement corrective actions when necessary Work with the genotyping team to develop recruitment strategies Contribute to the preparation, design and/or review of essential study documents, ethics and other required local/national submission requirements Input into the identification and selection of genotyping investigators as per clinical operations strategy Adopt a Risk Management approach to oversight and execution of genotyping initiatives Prepare study training materials and present at Internal Workshops, Investigator sites and any other external meetings Ensure study certifications, insurance, licenses and registrations are maintained where appropriate Experience required: Minimum 3 years’ experience working as a Clinical Project Manager in Phase I-IV studies within the pharmaceutical industry or a CRO Extensive experience in direct management of study start up activities Independent thinker with ability to anticipate issues and risks and to mitigate accordingly Creative thinker who can troubleshoot issues and think outside of the box to achieve Project goals Team player who is able to prioritise workload in a fast-paced environment An individual willing to embrace the culture of the Company, and work to instil the values of the Department within their working relationships For more information please reach out ASAP!... - Permanent - Full-time

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