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Clinical Trial Manager

Exciting CTM position within 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 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 Clinical Trial Manager, you will join the Clinical Operations team in a role with an international scope. Symphogen’s clinical trials are conducted in close collaboration with CROs and internal functions. As a Clinical Trial Manager, you will assist with overseeing the CROs deliverables and performance for outsourced trials.

In collaboration with the colleagues and CRO teams, the Clinical Trial Manager is responsible of delivering high quality trial execution within timelines and budget.

With direct report to Director IND & Phase I.

Your main tasks are:

  • Provide input when designing, planning, and conducting clinical trials to explore and document a compound’s activity in terms of safety and efficacy
  • Working closely with the Senior Clinical Trial Manager to define programme targets for clinical monitoring staff and ensure work is documented within the contracted project scope.
  • Coordinating activities at CROs
  • Development and implementation of Clinical Monitoring Plan
  • Responsibility for ensuring the needs of the CROs are met by facilitating the monitoring processes

Your qualifications are a couple of years’ experience as CTM in a pharmaceutical/biotech company or CRO environment within oncology. Alternatively, you have worked as a Senior/Lead CRA. 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 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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