ICON plc
ICON plc
ICON plc ir globāla līgumizpētes organizācija, kas apkalpo veselības aprūpes un farmācijas nozares. Tās darbība ietver klīniskos, konsultāciju un komerciālos pakalpojumus, kas atbalsta zāļu izstrādi no agrīnas izpētes līdz darbībām pēc zāļu nonākšanas tirgū. Uzņēmums piedāvā decentralizētus klīniskos pētījumus, sirds drošuma novērtēšanu, agrīnās klīniskās laboratorijas pakalpojumus, medicīnisko attēlveidošanu, regulatīvo informāciju un reālās pasaules pierādījumu risinājumus. ICON plc ir arī terapeitiskā kompetence tādās jomās kā sirds un asinsvadu slimības, onkoloģija, iekšķīgās slimības, šūnu un gēnu terapijas, kā arī bioloģiski līdzīgas zāles. Apvienojot datu analīzi ar uz pacientu vērstām pieejām, uzņēmums palīdz attīstīt klīniskās programmas.

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.

Apraksts

  • 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.

Prasības

  • 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.

Priekšrocības

  • 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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