Country Study Start Up Specialist (Buenos Aires)

Country Study Start Up Specialist (Buenos Aires)

01 oct
|
Abbvie
|
Buenos Aires

01 oct

Abbvie

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

​The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.​

• Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies. Competency in establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs.



Proactively identify and communicate issues impacting delivery and providing proposed solutions.
• Attend regional/area start up calls and providei input for assigned sites/studies. Collection of essential documents from sites and completing quality check (ALCOA).
• Compile and submit ethics and other required local document packages including customization of ICFs, patient facing materials and safety reporting.
• Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements.
• Collaborate with contract manager, Site Monitor, Area CSM Lead as required to assure timely site activation. Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas.
• Trigger clinical supply shipments. Complete IP release activities and triggering IP shipment. Issue site green light letter and activating sites i

📌 Country Study Start Up Specialist (Buenos Aires)
🏢 Abbvie
📍 Buenos Aires

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