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Senior Clinical Trial Associate

The Role

We are looking for an experienced and dedicated Senior Clinical Trial Associate (CTA) to be part of Global Clinical Operations at our Headquarters in Copenhagen.

Global Clinical Operations is part of Genmab Clinical Development and is responsible for managing the Genmab clinical cancer trials from early phase trials (FIH) to late stage trials while ensuring processes lives up to regulations and business ethics.

The work environment is within a global setting and characterized by people empowerment, new challenges, and devoted and talented colleagues.

In this position, you will be responsible for providing assistance to the Clinical Trial Manager on a number of clinical trials in all relevant aspects of trial preparation, trial conduct, documentation, and archiving.

Responsibilities

  • Responsible for setting-up, maintaining, reviewing, QC, and file trial related documents in the eTMF system

  • Support ongoing updates of the trial dashboard, trial budget maintenance and development

  • Handle insurances

  • Arrange internal and external meetings, prepare agendas and write minutes, support QC and development of graphical presentations etc.

  • Main driver of sponsor oversight on the eTMF documents twice a year

 

Additionally, the role can also involve tasks related to departmental activities such as:

  • Development of processes, templates, SOPs and WIs

  • Tracking of trial related documents etc.

  • Maintenance of department dossier

  • Development and maintenance of department share point site

  • Training of new employees

  • Support to student workers

 

Requirements

  • You have a background as Clinical Trial Associate from a similar position or have an education as registered nurse or similar

  • Preferably you have worked at least 3 years in an administrative position within the Pharmaceutical industry and are experienced in the planning and execution of clinical trials

  • You are proficient with both written and spoken English

  • You are highly skilled within MS Office and have flair for using IT systems

 

Moreover, you meet the following personal requirements:

  • You are organized and structured with a sense of details

  • You have the ability to work in an environment with many competing priorities

  • You are service minded

  • You are able to work independently as well as in global teams

  • You have a quality mind set and are able to prioritize your work in a fast paced and changing environment

  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab

Degrees of interest: Background as Clinical Trial Associate from a similar position

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