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.