Study Start-Up Specialist - Freelance

TFS HealthScience; Mainz; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading Contract Research Organization is seeking a Study Start-Up Specialist in Mainz, Germany. The role involves executing start-up activities, managing regulatory submissions, and ensuring timely site activation. Ideal candidates should have a Bachelor's degree and 1-3 years of clinical research experience. Competitive compensation and benefits are offered, fostering professional growth within a collaborative team environment.

Leistungen

Competitive compensation package

Comprehensive benefits

Opportunities for personal and professional growth

Qualifikationen

• 1-3 years of relevant clinical research experience.
• Understanding of ICH/GCP and regulatory requirements.
• Experience with start-up documents and sites preferred.

Aufgaben

• Execute end-to-end start-up activities for studies.
• Manage regulatory and investigator documents.
• Ensure contracts and regulatory approvals are completed.

Kenntnisse

Communication skills

Organizational skills

Teamwork

Regulatory understanding

Computer skills

Ausbildung

Bachelor’s degree

Jobbeschreibung

About this role

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.

The Study Start-Up Specialist supports project teams by executing study start-up activities in compliance with regulatory requirements, ICH/GCP, and TFS/client SOPs. The role ensures timely site activation through feasibility, regulatory submissions, contract support, and documentation oversight.

Key Responsibilities:

• Execute end-to-end start-up activities for assigned studies (country/region level), including feasibility, site identification, site initiation support, and start-up progress reporting, ensuring timelines, scope, and compliance with ICH/GCP, SOPs, protocols, and regulatory requirements.
• Collect, review, approve, track, and quality-check all regulatory and investigator documents; prepare and manage IEC/IRB submissions, amendments, regulatory fees, and collaborate with Regulatory on Health Authority/Competent Authority notifications.
• Lead local adaptation and documentation of Informed Consent Forms; ensure contracts are fully executed, regulatory approvals are granted, IP release is authorized, and all conditions for site activation are fulfilled.
• Maintain complete, accurate, and timely start-up documentation in CTMS, TMF, SMF, and central repositories; ensure proper submission of materials to TMF; support SSU Lead/PM with project set-up, Greenlight activities, and site activation processes.
• Support audits and inspections; provide feedback on site performance; participate in continuous improvement initiatives and cross-functional collaboration to enhance clinical operations.

Qualifications:

• Bachelor’s degree preferred; minimum 1–3 years of relevant clinical research experience.
• Good understanding of ICH/GCP, local regulatory requirements, SOPs, and corporate standards.
• Experience with investigator start-up documents and investigative sites is preferred.
• Strong communication, organizational, and cross-functional teamwork skills.
• Ability to manage multiple priorities in a fast-paced environment; strong computer skills.

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 27 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 800 professionals, TFS delivers tailored clinical research services in more than 40 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.