Quality Project Implementation Lead
4 weeks ago
Reporting to the Portfolio Lead, the Clinical Project Director will take a hands-on role in driving activities for their client's new Phase II study to develop treatments for a Rare Disease. Working remotely with occasional travel to the London Head Quarters, you will be joining a small team which is expected to grow, and you will be a key contributor to ensuring the successful running of a new, global Phase II multi-regional trial.
Oversee clinical trial activities from study start-up through database lock and final study report for one or more clinical programs, ensuring studies are delivered to agreed timelines, quality, and budget.
# Make significant contributions to the planning and start-up of the trial including budget management.
# Be the point of contact for CROs, and monitor the activities of our client's Third Party vendors.
# Lead the operationalization of the clinical development plans and development and implementation of clinical project plans.
# Participate in the development, review, and implementation SOPs.
# Participate in vendor, site and CRO audits and conduct accompanying site monitoring visits.
# Support in the recruitment, hiring, and line management of Clinical Operations professionals when needed.
Minimum 10 years of clinical trial management experience in a biotechnology, pharmaceutical company or CRO. Experience building and managing a high-performing cross-functional team. Hands-on experience in study management and running global clinical trials. This opportunity is fully remote with occasional travel to the London Headquarters. You may sometimes be required to travel internationally to participating study sites.
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