Clinical Data Manager

 Jobomas DE
 Deutschland, Federal Republic of Germany
 vor 1 Tag, 19 Stunden
Health Data Specialists (HeaDS), is seeking a Clinical Data Manager to join its growing global interventional hematology/oncology clinical program in its global Data Management and Statistics department (DMS). Our DMS department works across multiple therapeutic areas and all study phases with multiple Sponsors on a global level. This position focusses mainly in early phase studies (phase I-II), giving a great opportunity to strengthen your expertise and progress your career by being part of a top skilled, experienced, highly motivated and enthusiastic team. Job Description: As a Clinical Data Manager in HeaDS: You will be permanently employed by HeaDS working in our DMS department, working across multiple Sponsors focusing on Phases I-II. You must have previous working experience in a clinical data management role within clinical research. You can work in several countries in EU (Ireland, Germany, Netherland, Italy, Greece). Minimum qualifications: BSc/MSc degree in mathematics, (bio) statistics, data science & other applied sciences, life science, pharmacy or related subject or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). Minimum 2 years’ work experience as Clinical Data Manager in Phase I-III Studies Excellent MS. Office command Excellent written and verbal communication skills in English Experience working with Medidata Rave will be considered as a plus. Main responsibilities: Implementation, monitoring and supervision of data management activities within assigned clinical trials, i.e. responsible to design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans and Data Management Plans (DMPs). Provide the study status updates with respect to data, using standard reports (CPT, data entry, queries, SDV, safety reconciliation etc.) and communicate efficiently the status to the team. Creation and execution of data quality checks throughout study conduct Day to day responsibilities (under the guidance of senior personnel) may include but are not limited to: data review, open/close queries in the eCRF, medical coding, central lab data reconciliation, PK data reconciliation, add-hoc data reports creation, User Acceptance Testing (UAT) of internal and external electronic Data Capture systems. Provides support to the resolution of issues and inputting ideas to help resolve issues and contribute to continuous improvement. Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment. Competitive remuneration package comes on top.

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