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Study Start-Up Associate II (Healthcare, Remote)

Copenhagen, Capital Region
Posted 2 weeks, 3 days ago
Healthcare

About the role

Job summary

This role involves leading the initiation of clinical trials, ensuring compliance with regulatory standards, and supporting innovative treatments and therapies.

Qualifications

  • Bachelor's degree in life sciences or a related discipline.
  • At least 2 years of experience in clinical research or regulatory affairs, particularly in study start-up activities.
  • Strong knowledge of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulations.

Responsibilities

  • Oversee the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
  • Coordinate with internal and external stakeholders to secure necessary approvals for study initiation.
  • Maintain accurate records of regulatory submissions and correspondence.
  • Provide guidance to study teams on regulatory requirements and best practices.
  • Engage in process improvement initiatives to enhance study start-up efficiency.

Skills

Benefits

  • Excellent organizational and project management abilities.
  • Strong communication and interpersonal skills for effective collaboration with cross-functional teams.
  • Competitive salary and various annual leave entitlements.
  • Health insurance options tailored to family needs.
  • Retirement planning offerings to support future savings.
  • Access to a global Employee Assistance Programme for well-being support.
  • Flexible optional benefits, including childcare vouchers and discounted gym memberships.
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