Vacancy List Details

Vacancy List Details


Lead Clinical Research Associate

Copenhagen, Denmark

We are looking for an experienced and dedicated Lead Clinical Research Associate (Lead CRA) 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 empower-ment, new challenges and devoted and talented colleagues.

Job content
As Lead CRA you will be responsible for the planning, conduct and coordination of trial oversight activities with internal and external stakeholders to ensure quality and integrity of the data within and across Genmab clinical trials. In addition you will support the Clinical Trial Manager (CTM) with identification of investigators, build relationship with investigators/trial sites and conduct sponsor site visits to support recruitment and ensure compliance. Activities will be conducted in compliance with SOPs, ICH GCP and relevant guidelines.

You will support the CTM  in securing timely delivery and review of trial related documents, plans including but not limited to master PI/ICF, training records and monitoring visit reports, attend PTVs and SIVs and perform ongoing co-monitoring of the trials. As Lead CRA you will be responsible for ensuring proper documentation and record management is kept on the trials at all times.

Professional profile 
• Minimum 3+ years’ experience with monitoring and/or co-monitoring of clinical trials
• Preferably 3 years’ experience as trial manager, Lead CRA from a CRO and/or pharmaceutical company
• Extensive knowledge of working with trial oversight activities is a re-quirement
• You are proficient with both written and spoken English

Personal profile 
• You are structured and process oriented 
• You have a quality mindset and are able to prioritize your work in a fast paced and changing environment
• You have good interpersonal and communication skills during interactions with investigators  and other external and internal stakeholders
• You are able to work independently as well as within global teams
• You are a dedicated team player and an inspiring communicator with excellent social skills
• You are result- and goal-oriented and committed to contributing to the overall success of Genmab

Our Company 
At Genmab we strive to improve the lives of cancer patients by creating and developing innovative antibody therapeutics.  With two marketed products and a robust pipeline of differentiated antibodies, Genmab is working to transform the treatment of cancer.  
We are motivated by knowing that our work has the potential to make a real difference for cancer patients and their families.  Our culture values innovation, determination, teamwork, and integrity. We work cross-functionally and internationally as one global team, while individuals and local teams have the autonomy to drive the development of innovative products and technologies that could provide next generation cancer treat-ments. Please refer to our homepage www.genmab.com/careers for more information about working at Genmab.

For more information on this vacancy, please contact Majken Westergaard, Senior Director, Head of Clinical Operations or Sanne Byskov Klinke, HR &Administration Associate at +45 70 20 27 28

Deadline for applicants: As soon as possible - interviews will be conducted on an ongoing basis
Location: Copenhagen, Denmark
How to apply: Please mark your application 'Lead CRA' and send it to job@genmab.com