Description:
The Area Site Management Lead is responsible and accountable for directing CRAs in a matrix environment and for driving the successful execution of Clinical Site Management (CSM) study deliverables for their assigned studies within their geographical Area. ASMLs are study experts and provide monitoring expertise and ensure on-time and quality CSM deliverables (data, monitoring plan, SOPs, regulations). Review site and CRA outputs for compliance with protocol and monitoring plans. Function as a liaison and primary contact between CRAs and GSML.
- Manage and oversee day-to-day monitoring activities on assigned study/is to ensure CSM deliverables are met by tracking and maintaining project metrics and status of deliverables. Proactively communicate and escalate issues, risks and mitigation plans to Area/Country Leadership and GSML.
- Proactively communicate and support planning with Country teams (COM / CCOM) the CSM resources in alignment with the study deliverables and milestones.
- Proactive support and management of database lock efforts
- Primary point of contact for CRAs for study and site questions.
- Ensure country/area planned/LBEs timelines are aligned with overall study planning. Accountable for creating and driving recruitment plans for their assigned study(is) within their geographic Area.
- Accountable for delivering site selection per targets at country/area level.
- Represent Area as part of a coordinated study leadership team directed by the GSML in the delivery of on-time and on-target quality CSM deliverables.
- Review completed Site Feasibility Questionnaires, ensures adherence to monitoring plans (SEV, STV, on-site/off-site, COV) for assigned study/is.
- Conduct trending, assessment of risk, mitigation plans, root cause analysis for issues and emerging issues. Partner with GSML and C/COM on issue identification and addressing issues.
- Develop monitoring tools for trial, drive implementation and ensure consistency across area. Provide monitoring plan training and ongoing non-clinical CRA training.
- Conduct CRA teleconferences to deliver training and information as required. Attend study team meetings as applicable and disseminate information, as necessary.
- Collaborate with GSML in review of study specific eCRFs, completion guidelines, protocol deviation specifications, user acceptance testing, etc.
- Liaise with study-start-up to ensure timely site start-up. Accountable for recruitment across assigned areas/studies and collaborate with other ASMLs/GSML to accomplish recruitment for the trial.
- Ensure accuracy, completeness and timeliness of TESLA and other systems (e.g., LBEs for site/country events/milestones)
- Ensure issues/observations are entered, escalated, and actioned in a timely manner. Analyze for emerging trends and escalate to GSML and Area leadership as appropriate.
- Contribute to ongoing process improvement initiatives within their geographic area.
- Work across areas or globally depending on site distribution.
- Serve as an AdaptiV ambassador ensuring implementation and ensuring risk-based thinking on trial.
- May conduct joint visits with CRAs at challenging sites, as needed.
- Ensures audit/inspection readiness at country/site level, incl. TMF completeness.
- Maintain knowledge of ICH/GCP, regulatory requirements, AbbVie SOPs, therapeutic area (protocol, amendments).