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Senior Clinical Trial Associate

  • Genmab
  • 1000København K,Danmark
  • 04/01/2023
Fuldtid

Jobbeskrivelse

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 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 Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer. At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do. We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information. Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract. Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website https://www.genmab.com/privacy. Scam alert Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation. This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.