tmf group 관련 취업정보

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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 is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html