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Clinical Trial Manager – experience with clinical pharmacology trials

Exciting position in a progressive and innovative biopharmaceutical company

As Clincial Trial Manager – with focus on clinical pharmacology trials at Orphazyme you will join a dedicated team of professionals and become an important part of the Clinical Development staff in a progressive and innovate Danish biopharmaceutical company with a late stage pipeline. Orphazyme is based in Copenhagen and you will have direct report to VP, Head of Clinical Operations, and will refer to the Clinical Development Team Lead.

The position is newly established, and you will have the main responsibility for the successful end-to-end clinical trial execution from point of receiving scope (Trial Synopsis) through to project closure (Inspection ready TMF), initially on clincal pharmacology  trials (Phase I). Moreover, you will lead a cross-functional sponsor team, providing management and oversight of CRO/vendor deliverables.

Your main tasks are:

  • Management of triple constraints; time, budget, quality
  • Develop operational plans
  • Vendor selection/management
  • Oversight of CRO
  • Coordination of all delivery with input from Clinical Pharmacologist, Medical Director, Safety, Regulatory, Data Manager, Statistician, Clinical Trial Administrator and Clinical Trial Supplies
  • Active identification and management of trial related risks
  • Identify and contribute to areas of best practice and process improvements

Your qualifications include a minimum of 5-10 years of clinical trial experience, and you have experience within clinical pharmacology trials. You have experience in collaborating with phase 1 units, clinical CROs and are familiar with budget management and accruals. You are proficient in MS Excel, Word, and PowerPoint and knowledge of MS Project or similar is preferred. 

You have a M.Sc. or a similar relevant education. Most important is that you have the above mentioned experience.

You are a person with the ability to work collaboratively across multiple functions within the organization. You have a demonstrated ability to prioritize and manage multiple tasks/project simultaneously, and you have excellent written and verbal communication skills. You are well-organized and eager to learn, and you have excellent administrative skills. Finally, you enjoy working in a positive and informal environment. The right candidate for this position will bring a blend of clincial trial experience and an adaptive mindset allowing you to grow into a role which may develop over time in line with the company’s growth.

Orphazyme offers a unique opportunity to influence your own work as well as your personal and professional development. It is a position in a company in development with an exciting pipeline and a positive and informal environment.

Travelling: 5-10 days a year

Domicile: Central Copenhagen

For more details about the job, please contact Unique Human Capital, Research Consultant Jeanne Dederding, on M +45 28 74 58 71. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
T +45 7020 6700
/ /
cvr: 31502705
Stamholmen 157, 1. tv
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
Unique Human Capital Poland Sp. z o.o.
+48 531 785 064
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ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland