Ipsen Bioscience
posted 2 months ago
The Clinical Monitoring Lead (CML) at Ipsen Bioscience, Inc. is responsible for coordinating clinical monitoring activities and overseeing the clinical and site management activities of Contract Research Organizations (CROs) for assigned international Phase 2/3 clinical studies. This role is crucial in ensuring that all activities are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and Standard Operating Procedures (SOPs). The CML will work to uphold the highest standards of quality, timely delivery, and budget adherence, thereby contributing to the overall Clinical Development objectives and achieving clinical excellence. In this position, the CML will coordinate the achievement of assigned clinical study deliverables within a matrix organization, working closely with Clinical Project Managers (CPMs) and acting as an Ipsen representative at clinical sites to build strong relationships with investigators. The CML will ensure efficient study start-up by overseeing the CRO clinical team and collaborating with other relevant team members involved in the study setup, including Data Management (DM), Regulatory (Reg), and Chemistry, Manufacturing, and Controls (CMC) teams. This includes reviewing site feasibility reports, supporting CPMs in site selection, and ensuring timely collection of essential study documents. The CML will also be responsible for training Clinical Research Associates (CRAs) on study-specific operational activities, preparing necessary documents for monitoring and reporting, and customizing Key Risk/Performance Indicator templates. The role involves co-monitoring clinical studies, ensuring adequate contact with investigator sites, and participating in ongoing clinical study data reviews. The CML will maintain and review key clinical documents required for Clinical Study Reports (CSRs) and assist in audit preparations and follow-ups. Additionally, the CML will contribute to the efficient operation of the Therapeutic Area (TA) Group and participate in various initiatives, including SOP updates and training material reviews. The position requires compliance with Environmental Health and Safety (EHS) regulations and participation in mandatory EHS training. Overall, the CML plays a pivotal role in ensuring the successful execution of clinical studies while adhering to Ipsen's global standards and regulations.