Study Start Up Specialist

Freelance Study Start-Up Specialist – 12‑Month Contract

We are seeking an experienced Study Start-Up Specialist to join a dynamic clinical research team on a 12-month freelance contract . This is a hands‑on role supporting the initiation of clinical trials, ensuring regulatory compliance, and facilitating the efficient start‑up of studies.

Key Responsibilities:

• Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and communications with regulatory agencies.
• Coordinate with internal teams, CROs, and external stakeholders to obtain approvals and authorizations for study initiation.
• Maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
• Provide guidance and support to study teams on regulatory requirements and best practices for study start‑up activities.
• Participate in process improvement initiatives to enhance study start‑up efficiency and effectiveness.

Required Experience & Skills:

• Bachelor’s degree in Life Sciences or a related field.
• Minimum of 2 years’ experience in clinical research or regulatory affairs, including specific experience in study start‑up activities.
• Strong understanding of ICH‑GCP and local regulatory requirements for clinical trials.
• Excellent organizational and project management skills, with the ability to manage multiple tasks simultaneously.
• Strong communication and interpersonal skills, with the ability to collaborate effectively across cross‑functional teams.

Additional Details:

• 12-month freelance contract.
• Fully remote or hybrid depending on project requirements.

This contract role is ideal for a motivated clinical professional who thrives in a fast‑paced, collaborative environment and wants to play a key role in the successful initiation of clinical trials.