Senior Clinical Monitoring Lead
il y a 5 jours
The Senior Clinical Monitoring lead is fully accountable for all 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 GCP guidelines and regulations.
- He/she builds strong relationships with investigators and proactively acts as a site engagement lead and an Ipsen Ambassador.
- The Senior CML coordinates the achievement of assigned clinical study deliverables within a matrix organization in close collaboration with the Clinical Project Manager.
- The Senior CML, as requested, will act as CML lead for complex studies that involve several CMLs providing oversight in alignment with the Clinical Project Manager and Clinical Program Director.
- Sr. CML will mentor, coach other CMLs in the CDO organization and also work on transversal initiatives and process improvement.
**clinical study set up activities coordination & oversight responsibilities**:
- 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, to ensure appropriate strategy is in place for the country/site selection for the success of the study in collaboration with the CPM/Clinical Program Director and ensure validation of the study feasibility report by the TA CDO head
- Ensure efficient and thorough study start-up, either directly if internally managed, or by overseeing the Clinical team of the CROs and working closely cross-functionally 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 pro-actively managed and performed prior to each site initiation, as per the oversight plan.
- Ensure timely site contract negotiation and compliance of the site budget per agreed fair market value (FMV) at country level, including site overheads and patients stipends and compensation
- Contribute to establish the participant recruitment strategy to ensure materials are developed and submitted to IRBs/ECs (local/central advertising), contract with site include correct languages and adequate fees (referral network, participation to sponsor & sites calls)
- 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 (Participate in the development of the eCRFs, eCOA, randomization and supplies workflow set up and participate in the UAT activities for all systems involved, as applicable)
- Responsible for reviewing the CRA training material and site facing materials (eg.,Protocol training, study manuals, vendor manuals etc) and coordinating the review of such documents to the other study team members as applicable (DM, CMC, MDD etc ). Validate the final clinical study documents (such as patient facing documents, study manual, monitoring plan) prepared by the Clinical CRO, as per the oversight plan.
- 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 in the RFP process to review the assumptions going into monitoring activities. Collaboration with the CPM in the RFP process and participation to BID defense meeting
- 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, data cleaning plan and clinical monitoring metrics ).
- Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan
- Ensure site initiation visits are occurring as planned.
- If applicable to set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations during start-up phase to discuss any potential sites we should c
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