31 ago
|
Allergan
|
Buenos Aires
31 ago
Allergan
Buenos Aires
Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
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.
- 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 regulations, guidelines and policies. May monitor regulatory reforms and industry trends within country / district, and provide impact analysis of significant changes affecting conduct of Clinical studies.
- Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation.
📌 Clinical Operations Manager Cluster South (Buenos Aires)
🏢 Allergan
📍 Buenos Aires