Local Study Manager

vor 10 Stunden

Hamburg, Hamburg, Deutschland TFS HealthScience Vollzeit

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 Local Study Manager is responsible for the planning, execution, and oversight of clinical studies at the country level, ensuring delivery of high-quality data within timelines, budget, and regulatory compliance.

As part of our SRS team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader in
Oncology drug development
.
Key Responsibilities

  • Lead and coordinate the execution of one or more oncology clinical studies at a local/country level.
  • Ensure compliance with ICH-GCP, regulatory requirements, and sponsor/CRO SOPs.
  • Oversee site feasibility, selection, initiation, monitoring, and close-out activities.
  • Act as the main point of contact for investigational sites, local study teams, and global counterparts.
  • Manage study timelines, budgets, and quality deliverables at the country level
  • Identify risks and implement mitigation strategies to ensure successful study delivery.

Qualifications

  • University degree in Life Sciences, Nursing, Pharmacy, or related field.
  • Minimum 3–5 years' experience in clinical research, with solid background in study management.
  • Proven expertise in Oncology studies within a CRO or pharmaceutical environment.
  • Strong knowledge of ICH-GCP guidelines and regulatory requirements.
  • Excellent organizational and communication skills, with ability to build effective relationships with investigators and stakeholders.
  • Fluent in both German and English (written and spoken).

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.

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