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AbbVie
AbbVie
H1B वीज़ा प्रायोजकपरामर्शविनिर्माणस्वास्थ्य सेवा
AbbVie एक वैश्विक दवा कंपनी है जो जटिल स्वास्थ्य स्थितियों के लिए औषधियों की खोज, विकास और उपलब्धता पर केंद्रित है। इसके उत्पाद पोर्टफोलियो में इम्यूनोलॉजी, ऑन्कोलॉजी, न्यूरोसाइंस और सौंदर्य चिकित्सा शामिल हैं, तथा कंपनी 175 से अधिक देशों में मरीजों की सेवा करने वाले परिचालनों के माध्यम से काम करती है। कंपनी का कार्य फार्मास्यूटिकल अनुसंधान, विनिर्माण और स्वास्थ्य सेवा विशेषज्ञता को जोड़ता है, जिसे वैज्ञानिक नवाचार तथा अनुसंधान और विकास में पर्याप्त निवेश का समर्थन प्राप्त है। AbbVie स्वास्थ्य परिणामों और समुदाय पर प्रभाव को बेहतर बनाने के अपने व्यापक दृष्टिकोण के हिस्से के रूप में विविधता, स्थिरता और मरीजों के सहयोग को भी महत्व देती है।
LinkedIn
कंपनी की नौकरियाँ

Senior Clinical Research Associate (Remote, Hungary)

AbbVie is hiring a Senior Clinical Research Associate to oversee clinical trial sites in Hungary. The role focuses on site monitoring, regulatory compliance, audit readiness, study execution, and CRA development.

HUहंगरीरिमोटपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीनैदानिक अनुसंधान
Google Cloud Platform

विवरण

  • Deliver protocol-level SMM activities for assigned sites and studies throughout start-up, execution, and close-out.
  • Conduct monitoring visits, site evaluations, selection and activation activities, close-out visits, and monitoring reports.
  • Identify and resolve site issues that could affect study timelines.
  • Keep clinical trial management systems updated with accurate site-level information.
  • Apply expertise in local regulatory and legal requirements.
  • Coordinate timely payments for assigned sites and studies.
  • Ensure compliance with regulations, GCP, ICH Guidelines, SOPs, Monitoring Plans, and quality standards.
  • Monitor changes to local regulations, guidelines, and policies.
  • Maintain audit and inspection readiness and advise on pre-audit GCP activities.
  • Prepare for and follow up on site audits and inspections, contributing to CAPA development.
  • Coach and mentor CRAs while supporting their professional development.
  • Act as the country contact for CROs when assigned.
  • Contribute to or lead global and local task forces and initiatives.
  • Identify training needs and help standardize and deliver training for SMM monitors when assigned.
  • Support onboarding and incorporate lessons learned into monitoring materials and best-practice curricula when assigned.
  • Serve as a country or district study contact when assigned.
  • Update Impact/Tesla with country planning data and LSR assignments when assigned.
  • Represent assigned studies globally when required.
  • Perform remote data reviews in line with the IDRP, Monitoring Plan, SOP/WI, timelines, and study objectives when assigned.
  • Provide regular feedback on investigator and site performance.
  • Build effective, collaborative relationships with peers and site monitors.

आवश्यकताएँ

  • Bachelor’s degree or equivalent in a health-related discipline, such as medicine, science, nursing, or pharmacy, is preferred.
  • At least three years of site monitoring experience.
  • Strong analytical and critical-thinking abilities.
  • Excellent interpersonal and persuasive communication skills.
  • Adaptability and flexibility when requirements change.
  • Resourceful, creative approach to problem-solving.
  • Proactive, positive, and collaborative team orientation.
  • Strong planning and organizational capabilities.
  • Ability to manage competing projects and deadlines in a dynamic environment.
  • Consistent commitment to business ethics and integrity.
  • Working knowledge of federal and applicable local regulations, GCP, ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards.
  • Knowledge of local regulatory and legal requirements.
  • Ability to maintain audit and inspection readiness.

लाभ

  • Option to work remotely.
  • Equal opportunity employer.
  • Work environment centered on integrity, innovation, improving lives, and community service.

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