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Senior Clinical Trial Manager

  • 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 Are you looking for an opportunity where you can take the lead in delivering key trial management elements on oncology trials and ensure sponsor engagement? We are looking for a (Senior) Clinical Trial Manager, someone driven by ensuring a one-team culture with CROs, and who excels in contributing to great teamwork and working environment. Join our innovative, hardworking, and ambitious team collaborating in a high-performing and fast-paced environment dedicated to improving the lives of cancer patients. As (Senior) Clinical Trial Manager (CTM) in Clinical Operations at Genmab, you will: Lead one or more trials ensuring that key project deliverables are met with the overall goal of developing new and innovative treatments for cancer. Lead the cross-functional trial-specific trial team, including the CROs, to deliver clinical trials within budget and timelines and according to quality standards defined by regulations, Genmab SOPs and ICH-GCP. In the Trial Management team in Clinical Operations, we are currently more than 60 highly motivated and experienced people located in Denmark, the US, the Netherlands, and Japan. Working in Clinical Operations is exciting, intense, challenging, and fun at the same time. The dedication, collaborative and knock-your-socks-off spirit of our employees are what really shapes our team. From Day One, the onboarding program makes sure that you accomplish trainings, get settled with our IT systems and that you team up with your mentor, colleagues, and relevant stakeholders. Responsibilities The (Senior) Clinical Trial Manager will plan, set up and execute clinical trials and will be responsible for successful delivery of key trial management elements. The principal responsibilities are: Lead the trial team and act as the overall responsible for trial related activities from start up to reporting of a clinical trial in close collaboration with internal stakeholders and CROs Secure trial deliverables in a proactive and motivational manner Communicate with and perform stakeholder management of CROs and other stakeholders throughout all stages of trial conduct Create good working environment by being a role model in great teamwork Ensure proper documentation, record management, risk assessment/management, trial budgets, as well as sponsor engagement and sponsor oversight activities Constantly develop and implement new and better clinical trial practices Act as Clinical Operations representative in Compound Development Teams Requirements A BSc or MSc degree within the medical, biological, pharmaceutical science or equivalent. Minimum of 3-4 years (7 years for Senior CTM) of experience with clinical trial management from a pharmaceutical company and/or CRO. Experience within the field of oncology and/or first-in-human trials is preferred. Proven skills from working in a project oriented and international organization. Minimum 2 years’ experience as Clinical Operations representative in Clinical Development Teams (CDTs) or Global Project Teams (GPTs) would be preferable. Excellent communication skills in English both written and spoken. Moreover, you meet the following personal requirements: Dedicated team player who enjoys leading teams and inspire trust among colleagues. Quality mindset and able to prioritize your work in a fast paced and changing environment. 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.