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ICON plc
ICON plc
ConsultingHealthcareLogistics
ICON plc is a global contract research organisation serving the healthcare and pharmaceutical industries. Its work spans clinical, consulting, and commercial services that support drug development from early research through post-marketing activities. The company provides solutions including decentralised clinical trials, cardiac safety, early clinical laboratories, medical imaging, regulatory intelligence, and real-world evidence. ICON plc also brings therapeutic expertise to areas such as cardiovascular disease, oncology, internal medicine, cell and gene therapies, and biosimilars, combining data analysis with patient-focused approaches to help advance clinical programmes.
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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.

USUnited StatesPAPennsylvaniaRemoteFull-timeJuniorMiddleEnglish RequiredClinical Operations
Google Cloud Platform

Description

  • 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.

Requirements

  • 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.

Benefits

  • 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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