Study Start Up Manager

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.

Currently we are looking for a Study Start Up 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 or Munich.

Key Responsibilities

• Manage and execute study start-up activities at country and site level in compliance with ICH-GCP and applicable regulations
• Prepare, review, track, and submit regulatory and ethics documentation to authorities and IEC/IRBs
• Maintain and report on site performance metrics and start-up milestones
• Collaborate closely with CRAs and the local study team to ensure efficient study start-up delivery
• Update CTMS and other systems in line with required timelines
• Ensure timely collection and quality of essential documents in the eTMF
• Follow up with sites to resolve outstanding start-up actions
• Participate in local study team meetings and provide regular status updates to line management

Qualifications:

• Bachelor's degree in life sciences or a related field
• Strong knowledge of ICH-GCP and local regulatory requirements
• Solid understanding of clinical study management and start-up processes
• Experience with EU and local/site submission processes
• Strong communication, collaboration, and organizational skills
• High attention to detail and ability to manage multiple priorities
• Cell therapy experience
• Ability to work 3 days per week from the office in Hamburg / Munich

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.