Area Site Management Lead
il y a 1 semaine
Your role at AbbVie
The Area Site Management Lead (ASML) 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).
You will review site and CRA outputs for compliance with protocol and monitoring plans. In addition, you function as a liaison and primary contact between CRAs and GSML.Primary responsibilities include but not limited to:
- 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 ontime and ontarget quality CSM deliverables.
- Review completed Site Feasibility Questionnaires, ensures adherence to monitoring plans (SEV, STV, onsite/offsite, 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 nonclinical 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 studystartup to ensure timely site startup. 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 riskbased 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).
Why AbbVie?
AbbVie has been at the top of the global 'Best Workplaces' list in Europe and worldwide for several years in a row.
We are proud of this This recognition by Great Place to Work is reflecting employee experiences of trust, innovation, company values and leadership.
It is an acknowledgement of being a fulfilling workplace, a recognition of our culture and the result of the ways we work together.
Join us at AbbVie, where medicine, aesthetics, and science are powered by some of the brightest minds in the world.
We are a dynamic biopharmaceutical company that offers you the resources you need and a global reach that empowers your innovative mindset.
From day one, we've known it takes teamwork, passion, and a culture built on diversity and inclusion to develop scientific breakthroughs, innovative pipelines, and treatments that change millions of people's lives around the world.
In short, we know it takes you to make those groundbreaking advancements happen.Are you looking for a relentless dedication to creating an environment where you will do your best, most innovative work? We offer that.
Complex challenges that allow you to improve lives on a global scale? We offer that too. A meaningful career where your continuous learning and development are top priorities? Well, we offer that too.Welcome to AbbVie. Ready to innovate together?
What we ask
- Bachelor's Degree or equivalent OUS degree, typically in (para)medical or scientific field highly preferred, or equivalent ye
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