Clinical Monitoring Lead

il y a 4 semaines

Les Ulis, France Ipsen Innovation (SAS) Temps plein

**Purpose of the position**
- Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Ph2/3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence.
- Coordinate the achievement of assigned clinical study deliverables within a matrix organization under the leadership of the Clinical Project Managers (CPM).
- Be an Ipsen representative at site and build relationship with our investigators.

**Main responsibilities and tasks**

**Ensure clinical activities coordination & oversight**
- 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 jeopardising 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 organisation 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)

**Ensure the monitoring oversight of different activities entrusted**
- Co-monitor clinical studies according to the oversight plan, ensuring adequate contact with investigator sites, identifying and solving issues in study progress, verifying data in-house or by conducting co-monitoring visits, in collaboration with other study team members, and following up as required with CROs/CRAs/investigator.
- Participate in the ongoing clinical study data reviews in collaboration with the other study team members.
- Make appropriate and timely reporting in CTMS (Ipsen’s Clinical Trial Management Tracking System), with regular checks for quality and accuracy.
- Ensure the agreed timelines for data collection (CRF/eCRF) and data clarifications/queries are met, sending information to data-management and monitoring CROs as appropriate.
- Ensure that study samples/assessments flow as required per protocol is well coordinated between the various stakeholders (CROs/Vendors/Ipsen departments) from site to the central facility/specialized lab.
- Participate in TMF quality check review regularly to ensure adequate completion during the study course with a final thorough review at the end of the trial prior to study archiving
- Participate in the preparation and follow-up of any other study systems (such as IWRS/IMP forecasting/ flow etc ), as required.
- Maintain and review key clinical documents required for Clinical Study Report (CSR), to ensure adequate quality (e.g. for CSR appendices publishing)
- As appropriate, participate in the preparation of study documents and perform site visits prior to audi

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