Study Start Up Associate

hace 2 días

Madrid, Madrid, España Icon plc A tiempo completo
Job Summary

We are seeking a highly skilled Study Start Up Associate II to join our team at ICON plc. As a key member of our clinical research organization, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

Key Responsibilities
  1. Regulatory Document Preparation: Prepare and submit regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
  2. Stakeholder Coordination: Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
  3. Record Management: Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
  4. Regulatory Guidance: Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
  5. Process Improvement: Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency.
Requirements
  1. Education: Bachelor's degree in life sciences or a related field.
  2. Experience: Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
  3. Regulatory Knowledge: Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
  4. Organizational Skills: Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
  5. Communication Skills: Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  6. Language Skills: Fluency in English and Dutch language.
What We Offer

At ICON plc, we value our employees and offer a range of benefits to support their well-being and career development. These include:

  1. Competitive Salary
  2. Annual Leave Entitlements
  3. Health Insurance
  4. Retirement Planning
  5. Employee Assistance Programme
  6. Life Assurance
  7. Flexible Benefits

We are an equal opportunity employer and are committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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