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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 â€� immunology, oncology, neuroscience, and eye care â€� and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atÌý. Follow @abbvie onÌý,Ìý,Ìý,Ìý,ÌýÌý²¹²Ô»åÌý.
The Country Study Start-Up SpecialistÌýproactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned countries or countries.
Responsibilities
- 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.ÌýProactively identify and communicate issues impacting delivery and providing proposed solutions.
- Attend regional/area start up calls and provide input for assigned sites/studies.Ìý Collection of essential documents from sites and completing quality check (ALCOA).Ìý
- 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.Ìý
- 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.ÌýIssue site green light letter and activating sites in IXRS. Track all start up and maintenance related activities in Vault SSU as appropriate.
- Maintain local country and site intelligence databases and EDLs in Vault.
- Maintain SSU performance metrics and KPIs for assigned sites/studies. Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads. Ensure audit/inspection readiness.
- Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.Ìý
- Participate in process improvement initiatives as required.Ìý
- Train and mentor new Specialists, Country Start Up.
Ìý
- Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required.
- A minimum of 1-2 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region.Ìý
- Familiar working within EU CTR and CTIS.
- Experience working with remote/virtual teams.
- Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
- Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment.Ìý
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.â€� Equal Opportunity Employer/Veterans/Disabled.Ìý
US & Puerto Rico only - to learn more, visitÌý
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