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Clinical Project Lead

Exciting opportunity to lead the clinical program for the groundbreaking Theranostics technology for several indications in preparation for a global commercial launch. 

 

As Clinical Project Lead for Curasight, you will be responsible for setting up, coordinating, and leading our clinical studies. 

Direct report to Hanne Damgaard Jensen, Chief Development Officer 

Your main tasks are: 

  • You will be heading the planning and implementation of the clinical program in cross-functional collaboration  
  • You will be collaborating with internal stakeholders and CROs, but also to varying degrees, with Study Sites/Centres, Primary Investigators, key opinion leaders, and ethical committees 
  • Develop and coordinate clinical, study-related documents, plans and training material 
  • Achieve study objectives and ensure study progress by working with CROs and study team members to set project priorities and milestones 
  • Ensure that study activities are completed in a timely manner 
  • Ensure compliance with relevant regulations, standards, and internal procedures 
  • Management of project milestones and proactively addressing deficiencies 
  • Lead efforts and plans for internal and external study-specific meetings 
  • Selecting, contracting and management of CRO performance 
  • Communicate with and perform stakeholder management of CROs and other stakeholders throughout all stages of trial conduct 
  • Participate in the selection of investigational sites 
  • Maintain effective communication with cross-functional teams and stakeholders 
  • Ensure proper documentation, record management, risk assessment/management, trial budgets as well as sponsor engagement and sponsor oversight activities 

Your qualifications include in-depth knowledge about clinical trial study methodology as well as extensive clinical project management experience for at least seven years, and you have demonstrated the ability to impact the execution and improvement of core clinical processes. Thorough knowledge of the clinical research process and experience with the clinical trial documentation for authorities. Familiarity with all aspects of setting up and maintaining QMS. You have been responsible for the selection of and management of CROs.

You have a BSc or MSc in Natural-, Health- or Pharmaceutical Science.

You bring an analytical, qualitative, and detail-focused approach while having critical reasoning skills, including the identification and resolution of complex problems, a quality mindset, and the ability to prioritise your work in a fast-paced and changing environment. Result- and goal-oriented and committed to contributing to the overall success of Curasight. You are flexible and work at ease in a high-performing organisation and international teams. You are structured and thrive by running complex projects to enhance and improve human life. You have excellent interpersonal and communication skills, high professionalism and respect, and a willingness to listen. 

As a person, you are a high performer with a documented track record of experience and deliverables, and you are an efficient communicator and have strong presentation and negotiation skills. You create consensus across professional and geographical borders and build trust among colleagues.

Curasight offers attractive conditions in a varied and exciting collaboration with scientific specialists who are leading global experts in their respective domains. The office resides in modern facilities in Copenhagen, Denmark, for housing management, research, and development. Curasight has a strong scientific and ambitious environment med dedicated employees who want to succeed as a team. 

Travelling: Limited, but travel related to the planning and implementation of clinical studies will be required. You will have the opportunity to participate at conferences and participate in the travel related to stakeholder management, for example, related to partners and advisory boards.

For more details about the job or the company, please contact CEO Jørn Duhn at M +45 21 75 19 25, E: jd@uhc.dk. Client Manager Gert Vium Andersen at M +45 42 95 08 83, E: gva@uhc.dk. 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
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