Company Description 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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description Purpose
The Sr. Specialist, Country Study Start Up proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries. For studies that only involve one country, the Sr. Specialist Country SSU is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities (i.e.: US only trials). Acts as a site start up expert and provides SME support and mentoring of Specialists, Country Start Up by delivering training and change management in the adoption of new technologies and processes. Note: Sr. Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU Leads.
Responsibilities
Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope inclusive of central and local IRB/EC sites. Establish 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 identifying and communicating issues impacting delivery and providing proposed solutions. Attend regional/area start up calls and providing input for assigned sites/studies. Collection of essential documents from sites and completing quality check (ALCOA). Compile and submitting ethics and other required local submissions 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, CRA, Area CSM Lead as required to assure timely site activation. Review 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. Drive to improve site start up efficiency, which includes leading process improvement initiatives. Function as a SME in the SSU community and leads training and mentoring of Specialists, Country Start Up, drive change management in the adoption of new technologies and processes. May act as area lead for studies that only involve one country (i.e.: US only trials).Train and mentor Specialists, Country Start Up.
Qualifications Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required. A minimum of 3 years of clinical research experience and preferably 2+ years of study start up management experience for the designated region. Must have hands on experience in interpreting regional clinical research regulations and processes. Experience working with central and local IRB/EC sites, inclusive of reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas. Adept and experienced working with Vault SSU in the capacity of essential document processing, IP release, and ICF IRB/EC review. Experience working with remote/virtual teams. Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making. Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements. Demonstration of successful start up execution and aptitude for managing multiple priorities in a fast-paced environment. Demonstration of driving and leading successful initiatives, special projects and activities that support the business. Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment.
Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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