Ipsen Bioscience - Cambridge, MA
posted 2 months ago
The Clinical Monitoring Lead (CML) at Ipsen Bioscience, Inc. is responsible for coordinating clinical monitoring activities and overseeing the clinical research organization (CRO) clinical/site management activities for assigned international Phase 2/3 clinical studies. This role is crucial in ensuring that all activities are conducted in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and standard operating procedures (SOPs) to maintain the highest standards of quality, timely delivery, and budget adherence. The CML will work closely with Clinical Project Managers (CPMs) to achieve clinical study deliverables within a matrix organization and will represent Ipsen at clinical sites, fostering relationships with investigators. Key responsibilities include ensuring efficient study start-up by overseeing the CRO clinical team, reviewing site feasibility reports, supporting CPMs in site selection, and verifying the timely collection of essential study documents. The CML will also assist in training Clinical Research Associates (CRAs) on study-specific operational activities and participate in the organization of monitor and investigator meetings. Additionally, the CML will prepare and assist in the production of documents necessary for monitoring and reporting clinical activities, customize site Key Risk/Performance Indicator templates, and validate final clinical study documents prepared by the CRO. The CML will co-monitor clinical studies according to the oversight plan, ensuring adequate contact with investigator sites, identifying and resolving issues in study progress, and verifying data accuracy. Participation in ongoing clinical study data reviews and ensuring compliance with timelines for data collection and clarifications are also essential functions of this role. The CML will maintain and review key clinical documents required for Clinical Study Reports (CSRs) and assist in audit preparations and follow-ups. This position requires a proactive approach, strong organizational skills, and the ability to work collaboratively within a multidisciplinary team.