(Senior) Clinical Trial Manager

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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.

Unique Human Capital is handling the recruitment. 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.

You can apply directly via this link: https://uhc.dk/en/available-jobs/senior-clinical-trial-manager/

Company

Symphogen is a subsidiary of Servier and antibody center of excellence primarily focused on oncology and immune oncology. We have a highly efficient antibody discovery and research platform supported by comprehensive early development capabilities.

Our antibody platform delivers antibodies with unique functionalities providing best or first in class potential as combination or mono therapy. Our approach and capabilities are well suited for combination therapies at the core of future cancer treatment.

Symphogen is located in Ballerup in the greater Copenhagen area. The company currently employs approximately 120 people

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