AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its 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.
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 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).
- Bachelor’s Degree or equivalent OUS degree, typically in (para)medical or scientific field.
- 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.
- Ability to create and deliver presentations.
- Able to work well within a matrix team in a fast-paced environment managing multiple priorities.
- Computer Literacy:
- Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.