
10,000+ employees
Founded 2013
đ„ Healthcare
đŒ Consulting
đ Manufacturing
Healthcare âą Consulting âą Manufacturing
AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.
đ„ 12 hours ago
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10,000+ employees
Founded 2013
đ„ Healthcare
đŒ Consulting
đ Manufacturing
Healthcare âą Consulting âą Manufacturing
AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.
âą Ensure successful protocol-level execution of SMM deliverables for assigned sites/studies, including study start-up, execution, and close-out âą Conduct and oversee monitoring visits, site evaluations, site selection and activation, monitoring close-out, and visit reports âą Anticipate and identify site issues affecting timelines and develop alternative solutions âą Maintain current clinical trial management systems with site-specific information âą Provide local regulatory and legal requirement expertise âą Ensure timely payment execution for assigned sites/studies according to clinical study agreements and local requirements âą Ensure audit and inspection readiness of assigned sites âą Advise on pre-audit activities for GCP requirements âą Prepare and follow up on site audits/inspections and provide input into CAPA preparation âą Coach and mentor CRAs and provide input into their development âą Serve as country point of contact for CROs when assigned âą Participate in or lead global/local task forces and initiatives âą Identify training needs and standardize/facilitate training solutions for SMM monitors globally when assigned âą Support onboarding, consolidate lessons learned, define best-practice training curricula, and maintain awareness of upcoming changes âą Serve as key point of contact in country/district for assigned studies when assigned âą Update Impact/Tesla with country-level information and planning timelines when assigned âą Act as global representative for one or more studies when assigned âą Conduct remote data review of assigned sites/studies according to applicable plans, SOPs/WIs, timelines, and objectives when assigned âą Provide ongoing feedback on investigator/site performance âą Build professional and collaborative relationships with peers and site monitors
âą Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred âą Minimum 5 years of site monitoring experience âą Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making âą Excellent interpersonal skills with the ability to communicate persuasively and with clarity âą Flexibility and adaptability to changing requirements âą Resourcefulness and creativity âą Demonstrated proactive and positive team player âą Strong planning and organizational skills âą High level of flexibility in a dynamic environment with competing projects and deadlines âą Demonstrated business ethics and integrity âą Adherence to federal and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and monitoring plans
âą Employees can work remotely âą Equal opportunity employer âą Commitment to operating with integrity, driving innovation, transforming lives and serving the community
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