Clinical Monitoring Lead

Cookie Notice* Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc.): ensure feasibility report are exhaustive, Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan.* Support and ensure that all specific Ipsen/CRO EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardizing the start of a trial.* Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organization and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)* Assist the CPM/ study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.* Prepare and/or assist in the production of all documents necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan and clinical monitoring metrics…).* Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan.* Validate the final clinical study documents (such as study manual, monitoring plan …) prepared by the Clinical CRO.* Review all/a sample of site visit reports as per the Oversight Monitoring Plan, ensuring timely and appropriate follow up of issues raised by monitors (Corporate & affiliates and/or CROs as appropriate).* If applicable, provide support and guidance to Internal CRAs (Ipsen Corporate & Affiliates with provision of some supervision in specific cases).* Coordinate and manage the CRO relationship, assisting CRO CRAs/CTLs when and where necessary.* Collaboration with the CPM in the RFP process and participation to BID defense meeting.* If applicable to set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations at various steps (site qualification, site recruitment)* 8+ years’ relevant experience in pharmaceutical drug development, with significant involvement in clinical research roles.* Minimum 1 year (ideally 2 years) as a Lead CRA, coordinating clinical/site management activities for international registrational studies (multiple sites/countries).* At least 3 years’ experience as a Field CRA monitor (CROs or Pharma Industry).* Experience managing and developing relationships with Contract Research Organizations (CROs).* Demonstrated experience preparing clinical study documentation for study set-up, maintenance, and close-out.* Experience working on global studies (multiple countries/sites).* Excellent knowledge of Good Clinical Practice (GCP), ICH regulations, and other relevant clinical study regulations.* Knowledge of Pharmaceutical Industry R&D and ability to work in a highly regulated environment within a Quality Management System (QMS).* Advanced proficiency with software applications (e.g., Word, Excel, PowerPoint, Adobe Reader) and basic financial knowledge (including use of financial tracking tools).* Strong organizational, coordination, interpersonal and coaching skills; able to organize, prioritize, and manage multiple tasks and deadlines.* Excellent verbal and written communication skills.* Ability to work effectively within teams and in a multidisciplinary, matrix environment.* Demonstrates professional awareness, integrity, a pragmatic/hands-on approach, and a proactive, flexible attitude.* Commitment to continuous learning and improvement in quality, timeliness, and cost-effectiveness.### Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. #J-18808-Ljbffr