ICON plc
ICON plc
ICON plc स्वास्थ्य सेवा और फार्मास्युटिकल उद्योगों को सेवाएँ प्रदान करने वाला एक वैश्विक कॉन्ट्रैक्ट रिसर्च संगठन है। इसका कार्य क्लिनिकल, परामर्श और वाणिज्यिक सेवाओं तक फैला है, जो शुरुआती अनुसंधान से लेकर विपणन-पश्चात गतिविधियों तक दवा विकास में सहायता करती हैं। कंपनी विकेंद्रीकृत क्लिनिकल परीक्षण, हृदय सुरक्षा, प्रारंभिक क्लिनिकल प्रयोगशालाएँ, मेडिकल इमेजिंग, नियामक इंटेलिजेंस और वास्तविक-विश्व साक्ष्य जैसी सेवाएँ प्रदान करती है। ICON plc हृदय रोग, ऑन्कोलॉजी, आंतरिक चिकित्सा, सेल और जीन थेरेपी तथा बायोसिमिलर जैसे क्षेत्रों में चिकित्सीय विशेषज्ञता भी उपलब्ध कराती है। डेटा विश्लेषण और रोगी-केंद्रित दृष्टिकोणों को मिलाकर कंपनी क्लिनिकल कार्यक्रमों को आगे बढ़ाने में मदद करती है।

Remote Clinical Operations Specialist, Pennsylvania — ICON plc

Lead regulatory submissions and site activation for ICON Strategic Solutions. Support clinical trial start-up and coordinate stakeholder approvals.

विवरण

  • Oversee clinical trial start-up while ensuring regulatory compliance.
  • Support site start-up and activation.
  • Prepare and submit clinical trial applications, ethics committee submissions, and communications with regulatory agencies.
  • Work with internal and external stakeholders to secure approvals and authorizations for study launch.
  • Maintain records of regulatory submissions, approvals, and related correspondence.
  • Advise study teams on regulatory obligations and effective start-up practices.
  • Help improve processes to make study start-up more efficient.

आवश्यकताएँ

  • Bachelor’s degree in life sciences or a related discipline.
  • At least two years of clinical research or regulatory affairs experience, including study start-up work.
  • Knowledge of clinical trial regulations and guidance, including ICH-GCP and local requirements.
  • Strong organization and project management skills, with the ability to prioritize competing tasks.
  • Clear communication and interpersonal skills for effective cross-functional collaboration.
  • Able to travel when needed, approximately 5%.
  • Legally authorized to work in the country where the position is based.

लाभ

  • Base salary with performance-related incentives.
  • Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
  • Retirement and pension plans.
  • Life assurance and disability coverage.
  • Employee assistance programs and wellbeing resources.
  • Structured training and career pathways for learning and development.

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