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AbbVie is a global biopharmaceutical company committed to discovering and delivering innovative medicines and solutions that solve serious health issues.
PRIMARY FUNCTION/OBJECTIVE
To enable AbbVie’ s emergence as a world class R&D organization, the position is accountable for all activities of site related study execution directly or by leadership of assigned CRAs involving start-up, execution, and close-out.
CORE JOB RESPONSIBILITIES
· Accountable for all activities of site related study execution of assigned studies / Monitors involving start-up, execution, and close-out. Accountable for the on-time and within budget study execution of assigned projects, including but not limiting to country and site feasibility.
· Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. Provide local regulatory and legal requirement expertise.
· Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local
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