Study Start Up Associate

AssociateGeneralFull TimeRemoteMid LevelTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Denmark

Posted

4 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglishGoogle Cloud Platform

Job Description

Study Start Up Associate

ICON plc

• Lead the initiation of clinical trials, ensuring compliance with regulatory requirements • Contribute to site start-up and activation activities, taking responsibility for deliverables and collaborating with others • Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions • Coordinate and liaise with internal and external stakeholders to obtain necessary approvals • Manage and maintain comprehensive and accurate records of regulatory submissions and correspondence • Provide guidance and support to study teams on regulatory requirements • Participate in process improvement initiatives to streamline study start-up processes

Job Requirements

  • Bachelor's degree in life sciences or a related field
  • Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
  • Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
  • Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
  • Willingness to travel as required (approximately 5%)

Benefits

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

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