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 clients 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 :

Bachelors 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. Youll 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.

Key Skills

Restaurant Experience,Customer Service,Employee Evaluation,Management Experience,Math,Employment & Labor Law,Sanitation,Leadership Experience,P&L Management,Mentoring,Supervising Experience,Restaurant Management

Employment Type : Full Time

Experience : years

Vacancy : 1