Local Study Manager (m/w/d) Cell Therapy

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.

About this role

Currently we are looking for a Local Study Manager for a direct recruitment for one of our clients, a Big Pharma company.

Please keep in mind that this is a hybrid position with 3 days per week at the client's office in Hamburg.

Key Responsibilities:

• Lead and manage global clinical trials within the DACH region, with a focus on cell therapy studies

• Ensure studies are conducted in compliance with ICH-GCP, applicable regulatory requirements, and global and local SOPs

• Take ownership of study timelines, quality, resources, and budgets at local level

• Plan and deliver patient recruitment targets and key study milestones

• Manage local study budgets, including planning, monitoring, and cost control

• Oversee and support the execution of internal and external contracts

Qualifications:

• University degree in life sciences, pharmacy, medicine, or a comparable qualification

• Several years of experience in clinical research in roles such as Project Manager, Clinical Lead, or Study Manager

• Solid experience in clinical study coordination within the pharmaceutical industry or a CRO

• Strong knowledge of regulatory requirements and clinical trial processes

• Fluency in German and English , both written and spoken

• Excellent communication skills, strong team orientation, and confident stakeholder management

• Structured, analytical working style with strong problem-solving skills

• At least 2 years experience within cell therapy / gene therapy / CAR-T

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 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

#Together we make a difference