Drives country and site study start-up and maintenance activities, including regulatory and ethics submissions, essential document collection, site activation, clinical supply release, database maintenance, KPI tracking, and inspection readiness. Collaborates with regulatory, contracts, clinical operations, and site monitoring teams to resolve issues and meet activation timelines. Ensures compliance with ICH, GCP, corporate policies, and local regulations. Also supports process improvement and mentors new specialists.
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.co.uk. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job DescriptionThe 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 in IXRS. Track all start up and maintenance related activities in Vault SSU as appropriate.
- Maintain local country and site intelligence database 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.
- Participate in process improvement initiatives as required.
- Train and mentor new Specialists, Country Start Up
- Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required
- A minimum of clinical research experience and preferably of study start up management experience for the designated region.
- 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.
- Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment.
- Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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AbbVie London, England Office
London, United Kingdom
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