Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases. The Role The Data Manager/Senior Data Manager supports data management tasks for DM study start up. This individual supports study start up tasks/processes to ensure efficiency and data quality throughout the life of the clinical trial. Key Accountabilities Responsible for overseeing the data management study start-up activities of assigned protocols within trial timelines (protocol review through to eCRF go-live) and ensures high quality clinical trial data collection. Ensures that data management activities comply with Genmab standard requirements; trial analysis and reporting needs; CDISC/CDASH guidance; ICH-GCP guidelines; Genmab SOPs and regulatory guidelines or regulations. Drives and owns the timelines for the completion of the study start up activities (e.g. eCRF, Data Validation Plan, etc.). Provides feedback and status updates to internal stakeholders on an ongoing basis. Identifies study start-up related issues and drives to resolution. Ensures the eCRF and subsequent database development is in alignment with Genmab data specifications by performing Sponsor UAT on EDC database, including electronic edits and form dynamic checks. Recommends both technical and process improvements based on review findings. Collaborates with the Clinical Data Standards Team to develop standards and ensures consistency and efficiency of the clinical trials. Skills & Experience The Data Manager requires a minimum of 3 years experience as a data manager in the pharmaceutical/CRO industry within the oncology therapeutic area; Senior Data Manager requires a minimum of 5 years experience. The level of this position will reflect the experience and seniority of the candidate. Extensive knowledge of eCRF design standards in oncology studies, CDISC/CDASH guidelines. Experience with RAVE and/or Marvin EDC systems is preferred. Knowledge of Qlik and SAS programming is an advantage. Other Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. 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 culture, all aiming to make a difference for cancer patients. Teamwork and respect are central pillars of Genmabs culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc. Genmab has selected Korn Ferry as a global recruitment partner to help us manage your application. When uploading your application, it will be transferred to Korn Ferry for their processing. By clicking apply now you will see how Korn Ferry manages your application and privacy. Associated topics: data architect, data engineer, data integration, data integrity, data management, data quality, database, database administrator, hbase, mongo database
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