*The expected hiring Job Grade will be G16 (Will be decided depending on the career experience and interview evaluation)
Purpose:
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.
Responsibilities:
・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 ontarget
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).
・Bachelor's Degree or equivalent OUS degree, typically in (para)medical or scientific field highly
preferred, or equivalent years of experience required.
・A minimum of 5 – 7 years of industry clinical research experience including 2 years of monitoring
or equivalent experience.
・Prefer candidates that have functioned as a lead CRA/ have equivalent experience. Experience in
multiple therapeutic areas or disease state/indications highly desired.
・Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple
perspectives and drive smart decision making.
・Excellent interpersonal skills with the ability to build trust, communicate with influence, clarity,
flexibility, and adaptability to changing requirements.
・Excellent planning, organizing and proactive prioritization skills; ability to work effectively and
efficiently in a dynamic, fast-paced environment.
・Strong ability to create and deliver presentations.
・Able to work well within a matrix team in a fast-paced environment managing multiple priorities.
・Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote
AbbVieは、誠実な事業運営、イノベーション推進、人々の生活の変革、地域社会への貢献、そしてダイバーシティ&インクルージョンの促進などに尽力しています。AbbVieの採用方針は、人種や肌の色、宗教、国籍、年齢、性別(妊娠を含む)、身体的・精神的障がい、病気、遺伝情報、性同一性または表現、性的指向、婚姻状況、退役軍人やその他法的に保護されたグループに属するかどうか等に関わらず、高い能力を持つ優秀人財を従業員や候補者として差別することなく雇用することです。
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