Study Start-Up Associate II (Healthcare, Remote)

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.