Clinical Monitoring Lead F/m

**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 Phase I to III 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.
- Be an Ipsen Ambassador at site and build strong relationship with our investigators.

Coordinate the achievement of assigned clinical study deliverables within a matrix organization under the leadership of the Clinical Project Managers (CPM). As Senior CML, takes responsibility of some study oversight in agreement with the CPM as described below.
- Can be designated as CML lead for studies where several CML are assigned: coordinating other CMLs to secure all task completed as per plan and be CML point of escalation, reporting to the study assigned CPM.

**Main responsibilities and tasks**

**Ensure clinical activities coordination & oversight**
- Ensure efficient and thorough study feasibility, either directly if internally managed, or by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study feasibility (MDD, Reg, digital etc ): ensure feasibility assessment is appropriately managed and reports are exhaustive. Prepare or Review site feasibility reports as per oversight plan, as applicable and support the CPM in site selection.
- Ensure efficient and thorough study start-up, either directly if internally managed, or 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 ):Verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, oversee site Clinical Trial Agreements preparation and control 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 and/or eCOA system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial.
- Ensure CRO CRAs are appropriately trained to study protocol and 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.
- Participate to the preparation of the internal Oversight Plan and review/comment associated documents managed by the CRO that are 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
- Review 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 defence 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)
- If applicable be the main CML contact for other study CMLs and ensure task and delegation between CML team is in place
- If applicable collate/review the feedback/findings from all CMLS to provide a holistic overview for the CPM/study team and assess for trends
- Be responsible for oversight and financial management of third party vendors as agreed with CPM (i.e. IWRS, Central lab)

**Ensure the monitoring oversight of different activities entrusted**
- Be an IPSEN Ambassador at site: create and build relationship with our Investigators, by discussing patient pathways, recruitment challenges and any other study specific topics in a problem-solving mindset, for Ipsen to become their partner of choice.
- Perform co-visits according to the oversight plan, ensuring adequate contact with investigator sites, identifying and solving issues in study progress,