Lead Clinical Research Associate - Freelance

TFS HealthScience; Mainz; Hybrid; EUR 50.000 - 70.000; Teilzeit

Zusammenfassung

A leading global Contract Research Organization is looking for a Freelance Lead Clinical Research Associate (Lead CRA) in Mainz, Germany. This role involves overseeing site-level clinical trial activities, ensuring compliance with ICH-GCP, and managing site evaluations and regulatory submissions. The ideal candidate has 6-8 years of CRA experience, including lead responsibilities, and fluency in both German and English. Enjoy competitive compensation and the flexibility of freelance work while contributing to impactful clinical trials.

Leistungen

Competitive compensation

Flexible freelance engagement

Qualifikationen

• Minimum 6–8 years of CRA experience, including Lead CRA or Senior CRA responsibilities.
• Proven experience with site contracting, budgeting, and regulatory submissions.
• Experience working with oncology, especially breast cancer required.

Aufgaben

• Lead local feasibility activities, including site identification and evaluation in Germany.
• Oversee CDA management, site contracting, and site budget negotiations in collaboration with sponsors and vendors.
• Manage regulatory submissions, amendments, and local authority interactions.
• Lead and perform site initiation, monitoring, and close-out activities.
• Provide proactive site management and communication.

Kenntnisse

Fluency in German and English (written and spoken)

Excellent communication and stakeholder management skills

Strong knowledge of ICH-GCP and EU regulations

Site contracting and budgeting experience

Experience in oncology and RWE studies

Ausbildung

University degree in Life Sciences, Pharmacy, Nursing, or related field

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 Provider (FSP) solutions.

The Freelance Lead Clinical Research Associate (Lead CRA) is responsible for leading and overseeing site-level clinical trial activities in Germany, ensuring studies are conducted in compliance with ICH-GCP, local regulations, sponsor SOPs, and project timelines.

As part of our SRS / FSP team, you will be dedicated to one sponsor, a global pharmaceutical company recognized as an industry leader in innovative drug development across multiple therapeutic areas.

Please keep in mind that this is a freelance opportunity for approximately 0.8-1.0 FTE.

Key Responsibilities

• Lead local feasibility activities, including site identification and evaluation in Germany
• Oversee CDA management, site contracting, and site budget negotiations in collaboration with sponsors and vendors
• Manage regulatory submissions, amendments, and local authority / ethics interactions
• Lead and perform site initiation, monitoring, and close-out activities, ensuring high-quality trial execution
• Provide proactive site management and communication, acting as the primary escalation point for site-related issues
• Ensure accurate local documentation management, including TMF / ISF completeness and inspection readiness

Qualifications

• University degree in Life Sciences, Pharmacy, Nursing, or a related field
• Minimum 6–8 years of CRA experience, including Lead CRA or Senior CRA responsibilities
• Strong knowledge of ICH-GCP, EU and German regulatory requirements
• Proven experience with site contracting, budgeting, and regulatory submissions
• Excellent communication and stakeholder management skills
• Fluency in German and English (written and spoken)
• Experience working with oncology, especially breast cancer required.
• Experience working with RWE, non-interventional studies is required.

What We Offer

We provide a competitive compensation structure, flexible freelance engagement, and the opportunity to work with a leading global sponsor on impactful clinical trials. You will be part of a collaborative and professional environment that values expertise, quality, and long-term partnerships—while maintaining the flexibility of freelance work.

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 guide our decisions at every level. By aligning on these values, we foster a culture of collaboration, innovation, and excellence—together making a difference for patients worldwide.