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Senior Clinical Trial Manager

The position offers a unique possibility to take part in the clinical development of both antibody and small molecule medicines.

 

To support Symphogen/Servier in the management of new projects, they are looking for an experienced and motivated Senior Clinical Trial Manager, who would like to be a part of their great innovative early development team in Denmark and a larger global team.

As a Senior Clinical Trial Manager, you are responsible for management of the different functions within the team and overseeing the CROs’ deliverables and performance for outsourced trials within oncology. Moreover, the role has an international scope, where the Senior Clinical Trial Manager will be responsible for clinical trials conducted in close collaboration with internal functions located globally.

With direct report to Director IND & Phase I.

Your main tasks are:

  • Responsibility for designing, planning, and conducting clinical trials to explore and document a compound’s activity in terms of safety and efficacy
  • Responsibility for managing and overseeing the process of conducting clinical trials from preparation of trial synopsis to reporting
  • Responsibility for coordinating collaborations with CROs and lead contract negotiations with CROs
  • Responsibility for providing input to the clinical development strategies, sourcing strategies, and interactions with regulatory authorities
  • Responsibility for adhering to and advancing the clinical operational procedures in the Department for Clinical Development
  • In collaboration with the colleagues and CRO teams, the Senior Clinical Trial Manager is responsible of delivering high quality trial execution within timelines and budget

Your qualifications are several years of experience as CTM in a pharmaceutical/biotech company or CRO environment within oncology. Preferably coming from a role with an international scope. Moreover, you have Clinical Trial Documentation/Good Clinical Practice (GCP) experience and functional knowledge of the clinical development process/GCPs/ICH guidelines. You understand applicable U.S. Food & Drug Administration (FDA) and European regulations and requirements. Finally, it is an advantage if you have experience working with CROs.

You have a Bachelor’s Degree in Life Sciences, related field, or equivalent job experience. Advanced degree or certification is preferred.

As a person, you are open-minded, and you are motivated by taking the responsibility as a project leader and able to work independently in a changing environment. You are driven and possess effective communication and organizational skills. Moreover, you have excellent interpersonal skills, are proactive, flexible, and a highly motivated team player with good sense of humor.

Symphogen offers a challenging and versatile job in an innovative, flexible, focused and committed biotech environment. Moreover, they offer strong cross-functional teamwork, room for individual performance and development, and passionate, inspiring, and fun colleagues.

Travelling: 5-10% yearly.

Domicile: Symphogen’s office in Ballerup.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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