Study Manager

Overview:We are seeking a dedicated and experienced Contract Study Manager to join our team in Copenhagen. This role involves managing the conduct of our upcoming clinical study, including all necessary applications and documentations. Additionally, we are looking for a specialist to develop Electronic Case Report Forms (E-CRFs) and manage our study database.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a biotech company that is in Copehagen, Denmark. FTE 0.5 

Study Manager Responsibilities:

• Coordinate and oversee the clinical study process.
• Submit applications to the Ethics Committee (EC).
• Manage informed consent forms 
• Maintain the Study Master File and study site files.
• Handle contracts with study sites.
• Commitment: 2-3 days per week, working from our Copenhagen office.

Qualifications:

• Proven experience in clinical study management.
• Familiarity with EC applications
• Strong organizational skills.
• Ability to manage multiple tasks efficiently.

Application Process:

Interested candidates are invited to submit the following:

• A detailed CV highlighting relevant experience.
• Expected remuneration and availability.

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.