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Clinical Document Manager, Clinical Operations, Clinical R&D

Driven by research and a passion for science Ferring Pharmaceuticals is a biopharmaceutical company dedicated to the development of innovative treatments that make a real difference in people’s lives all over the world. Active in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics, we develop medicine on the body's own terms. We believe in the power of people and research - and go where ideas and research take us. 

THE DEPARTMENT 

Clinical Operations are responsible for planning and execution of clinical trials in ph. 1- 4 within all therapeutic areas in Ferring. High quality trial data and adherence to timelines are important for us. To optimize the achievement of this a good and constructive teamwork and strong leadership abilities in accordance with our values are critical success factors.  

THE JOB 

You will be responsible for the quality, completeness and inspection readiness of the trial master files as defined in the trial specific trial master file plan. You will take the role as TMF Manager within Ferring’s electronic trial master file system and drive the process of document collection for trial master files in our clinical trials in collaboration with CRO and clinical team. 

Your essential tasks will be: 

  • Initiate and prepare the TMF Plan in collaboration with CRO and clinical team 
  • Ongoing quality control and trend analysis in accordance with the TMF Plan 
  • Oversight of availability and completeness of documents in the eTMF 
  • Collection, compilation and quality control of documents to clinical trial report appendices 
  • Training of CRO and clinical team in trial specific document handling processes 

QUALIFICATIONS 

You must have an educational background as Librarian DB, Cand. Scient. Bibl. or equivalent with experience from the pharmaceutical industry and with preferable 2 years previous experience with clinical documentation and trial master files.  

As a successful candidate we expect you to have high quality standards and to be detail-oriented. In addition, it is essential that you are well organized, proactive and a goal-oriented team player with the ability to work with multiple tasks in an international and multicultural environment. 

Excellent knowledge of MS Office and fluency in English with good verbal and written communication skills is a given. 

ADDITIONAL INFORMATION 

For additional information, please contact Associate Director Jennie Wilborgsson, phone: +45 28787194. Please send your application and CV in English via the application button as soon as possible but no later than the 15th January 2017 as we will review incoming applications on an ongoing basis.

Short Description:

Clinical Document Manager

Position Type:

Permanent

Workplace:

Copenhagen

Homepage:

www.ferring.dk

Ferring Pharmaceuticals is a growing organisation offering employees opportunities for personal development within an international environment. Working across teams, with different cultures, on different continents is not uncommon. Employees are encouraged and welcomed to bring forth new ideas, discuss concerns and share feedback with colleagues and management. It is this freedom and respect shown to all employees that makes Ferring an attractive place to work.
Closed for applications Gem job

Arbejdssted

Copenhagen

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