(Senior) Clinical Data Manager (m/f/d)

60306, Frankfurt am Main
07.08.2020

Daten dieser Anzeige

Job-ID: 015883946
(Senior) Clinical Data Manager (m/f/d)

Merz Aesthetics

Germany

https://merzpharma-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.jobinfo&jobid=1017&company_id=30120&version=1&source=ONLINE&jobOwner=992452&aid=1

You define trial specific data management procedures in Data Management Plans You coordinate (e)CRF development, administration and updates, including eCRF User Acceptance Tests and definition of User Roles and User Administration Procedures You define trial specific edit checks and discrepancy management procedures in Data Validation Plans You organize and specify transfers of data collected outside of the eCRF (e.g. ePROs) You define the content of regular status reports and distribute them You oversee medical coding using MedDRA and WHO-DD You conduct and oversee SAE reconciliation and resolution of resulting discrepancies You coordinate database freezes and close activities You archive the clinical database and subject (e)CRFs You optimize and update data management processes to reflect possible changes in regulatory requirements

  ABOUT US: Our leading position in the global market in the areas of Aesthetics, Therapeutics, and Consumer Care is the result of our innovative spirit and the commitment of our staff. Our highly attractive portfolio, a strong strategic focus, and dynamic characterize us as a company that is heading towards long-term growth and success. Do you share our enthusiasm for customer oriented work and are willing to take up the task of continuing to write our success story? Then join Merz Aesthetics, a division of Merz Pharmaceuticals GmbH, as       (Senior) Clinical Data Manager (m/f/d)  Biometrics Aesthetics part time 50% - limited for 24 months      THE FOLLOWING RESPONSIBILITIES ARE AWAITING YOU:   You define trial specific data management procedures in Data Management Plans You coordinate (e)CRF development, administration and updates, including eCRF User Acceptance Tests and definition of User Roles and User Administration Procedures You define trial specific edit checks and discrepancy management procedures in Data Validation Plans You organize and specify transfers of data collected outside of the eCRF (e.g. ePROs) You define the content of regular status reports and distribute them You oversee medical coding using MedDRA and WHO-DD You conduct and oversee SAE reconciliation and resolution of resulting discrepancies  You coordinate database freezes and close activities You archive the clinical database and subject (e)CRFs You optimize and update data management processes to reflect possible changes in regulatory requirements     WHAT WE EXPECT FROM YOU:    Graduate studies in Documentation, Medical Documentation, Medical Informatics, Bioinformatics, Natural Sciences or similar At least 3 years experience in Clinical Data Management  Business fluent in English (written and spoken) Familiarity with ICH, GCP, FDA guidelines Experience with EDC systems, ideally experience with SAS and CDISC data standards Strategic and analytical thinking Excellent communicating and team player skills High sense of responsibility and quality awarenessess  Analytical and highly Structured way of working     WHAT YOU CAN EXPECT FROM US:   Meaningful work and exciting projects from day one Collaboration in multi-functional and global teams Flexible work hours Attractive conditions and extensive social benefits Personal & professional development An open & international work environment in a global family-owned business Participation in the company programme "We care for your beauty"   YOUR APPLICATION:>> Hier bewerben         Then take the next step towards the future with a top employer in the heart of Frankfurt who will offer you freedom to make your own decisions right from the start.   We look forward to receiving your online application including your salary expectation, your earliest start date, and the code 1017-120.     For more information, visit us at www.merz.de.    

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Forschung & Entwicklung

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Teilzeit

Befristet

60306

Frankfurt am Main