[Hiring] Study Start Up Lead @TFS HealthScience

Role Description

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.

• 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.

Qualifications

• 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.
• Good to have: Experience in submissions in the US and Australia.

Benefits

• Competitive compensation package.
• Comprehensive benefits.
• Opportunity for personal and professional growth in a rewarding environment.
• Team values collaboration, innovation, and making a difference in the lives of patients.

Company Description

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

• Core values: Trust, Quality, Passion, Flexibility, and Sustainability.
• Guiding light for decision-making at all levels of the organization.
• High employee engagement and satisfaction through alignment on fundamental values.
• Cultivating a unified force geared towards innovation and excellence.