Study Start Up Lead

TFS HealthScience

12h

About The Position

As part of our CDS Dermatology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Study Start Up Lead is responsible for leading and coordinating study start-up activities from award through site activation, ensuring projects are delivered on time, within budget, and in compliance with applicable regulations and quality standards.

Requirements

Bachelor's degree in Life Sciences, Nursing, or a related field.
Minimum 4 years of clinical research experience with a strong focus on study start-up activities.
Good understanding of ICH-GCP guidelines and regulatory requirements.
Experience coordinating multiple projects in a fast-paced environment.
Strong organizational, planning, and problem-solving skills.
Excellent written and verbal communication skills in English.

Nice To Haves

Experience in submissions in the US and Australia.

Responsibilities

Lead and oversee study start-up activities across assigned projects from award to site activation.
Develop and maintain start-up plans, timelines, and project milestones.
Partner with Project Managers to identify risks and implement mitigation strategies.
Coordinate Ethics Committee (EC/IRB) submissions and collaborate with Regulatory teams on Health Authority requirements.
Support site feasibility, site activation, and greenlight processes.
Coordinate clinical trial agreement negotiations alongside Legal and operational teams.
Ensure study documentation is complete, accurate, and submitted to the Trial Master File.
Monitor start-up metrics and provide regular progress updates to project stakeholders.
Support continuous improvement initiatives, SOP development, and operational best practices.
Contribute to bid defenses, proposals, and business development activities when required.