ICON plc
ICON plc
ICON plc je globalna pogodbena raziskovalna organizacija, ki zagotavlja storitve za zdravstveno in farmacevtsko industrijo. Njeno delo vključuje klinične, svetovalne in komercialne storitve, ki podpirajo razvoj zdravil od zgodnjih raziskav do dejavnosti po prihodu na trg. Podjetje ponuja rešitve, kot so decentralizirane klinične raziskave, ocenjevanje srčne varnosti, laboratorijske storitve za zgodnje klinične raziskave, medicinsko slikanje, regulatorne informacije in dokazi iz resničnega sveta. ICON plc ima tudi terapevtsko strokovno znanje na področjih, kot so bolezni srca in ožilja, onkologija, interna medicina, celične in genske terapije ter podobna biološka zdravila, pri čemer združuje analizo podatkov s pristopi, osredotočenimi na paciente, da pomaga napredovati klinične programe.

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.

Opis

  • 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.

Zahteve

  • 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.

Ugodnosti

  • 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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