Study Start Up Lead

TFS HealthScience; Województwo mazowieckie; On-site; PLN 120,000 - 180,000; Full time

Job summary

TFS HealthScience in Poland is seeking a Study Start Up Lead to drive initiation activities from award through site activation. You will coordinate start-up plans, timelines, and milestones, ensuring projects stay on time and within budget while adhering to ICH-GCP and regulatory requirements.

The role requires strong organizational and communication skills, plus four years in clinical research. You will manage EC/IRB submissions, site feasibility, contract negotiations, and documentation, while

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.

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.

Skills

Study start-up

Regulatory submissions

Project coordination

ICH-GCP knowledge

English proficiency

Multi-project management

Education

Bachelor's degree

Job description

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Study Start Up Lead in Poland.

About This Role

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.

Key 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.

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.

What We Offer

We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

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.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.