Rainer Richter Email and Phone Number
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Rainer Richter personal email
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Data Management professional with > 20 years of experiences in cross functional teams and cooperation with development partners and Contract Research Organizations (CROs).Experienced in eCRF (Medidata RAVE) and electronic patient diaries.Customer orientated, open for out of the box thinking and pragmatic solutions considering underlying risk assessments.
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Senior Clinical Data ManagerBavarian Nordic Feb 2020 - PresentCopenhagen, Capital Region, Dk● Act as lead data manager with responsibility for multiple studies and ensuring consistency across studies where applicable.● Monitor data clean-up process performed by CRO’s from study start-up through data archiving.● Actively participate in the development and review of documents such as departmental SOPs, guidelines, data management plans, dataset transfer standards, WHODrug and MedDRA coding standards, CDISC standards, QC/QA, and data validation plans.● Collaborate with Clinical, Biostatistics, Statistical Programming, Drug Safety, Quality, CROs, technology providers, and other groups.● Ensure data integrity across projects following ICH, Good Clinical Practices (GCP) and Standard Operating Procedures (SOP).● Contribute to DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.● Works with study team and coordinate all data management functions. Manage coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedure.
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Data ManagerDie Grünenthal Gruppe Mar 2018 - Jan 2020Aachen, De• Steer and oversee set-up, conduct and close-out of data management activities • Ensure collection and retention of consistent and plausible data as basis for analysis and reporting• Provide operational input with regards to data management/data capture on project and trial level• Implement and manage e- systems/-solutions and ensure efficient -
E-Clinical Expert / Technical Data ManagerDie Grünenthal Gruppe Jan 2013 - Feb 2018Aachen, DeSpecified role implemented at Grünenthal to support the setup and management of eCRF and ePRO / eCOA within clinical trials.Provide input to context of clinical trial synopsis / protocol regarding the use of electronic tools (eTools) like eCRF, and electronical Clinical Outcome Assessment (eCOA)Support the section of eTool providersSupport implementation of medidata URL for GrünenthalAdministrator for medidata URL at GrünenthalSOP author
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Clinical Data ManagerDie Grünenthal Gruppe Aug 2003 - Dec 2012Aachen, DeResponsible Clinical Data Manager in the joint development of Tapentadol (Palexia/Nucynta) by Grünenthal and Johnson & JohnsonData Management representative in cross functional / cross company development teamsFirst use of electronic Case Report Forms (eCRF) system (medidata RAVE)Provided eCRF trainings for users, face-to-face and WebEx, inhouse and at investigator meetingsFirst use of electronic patient diary (ePRO)Supported ePRO provider in hands-on trainings during investigator meetingFunctional support and assessment of external providers (Data Management, ePRO services) during qualification visitsOverseeing data management activities of external providersOverseeing and managing cooperation with ePRO providersBudget trackingCoding of Adverse events and medical history with MedDRA
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Oracle ProgrammerDie Grünenthal Gruppe Nov 2001 - Jul 2003Aachen, DeTrained in Oracle SQL and System ValidationRetrospective and prospective validation of Clinical Data Management system Oracle at GrünenthalData entry, edit checks, filing
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TraineeEpa Europharma Apr 2001 - Sep 2001Trainee in Data Management during education to Medical Documentalist
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TraineeSchaper & Brümmer Gmbh & Co. Kg Oct 2000 - Dec 2000Salzgitter-Ringelheim, DeTrainee in Data Management during education to Medical Documentalist -
TraineeInstitut Für Medizinische Psychologie, Philipps University Marburg Jan 2000 - Mar 2000Trainee during education to Medical Documentalist
Rainer Richter Skills
Rainer Richter Education Details
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Deutsche Angestellten Akademie (Daa) / Schule Für Medizinische Dokumentation / Marburg / GermanyMedizinische Dokumentation
Frequently Asked Questions about Rainer Richter
What company does Rainer Richter work for?
Rainer Richter works for Bavarian Nordic
What is Rainer Richter's role at the current company?
Rainer Richter's current role is Senior Clinical Data Manager bei Bavarian Nordic.
What is Rainer Richter's email address?
Rainer Richter's email address is ra****@****hal.com
What is Rainer Richter's direct phone number?
Rainer Richter's direct phone number is +4924156*****
What schools did Rainer Richter attend?
Rainer Richter attended Deutsche Angestellten Akademie (Daa) / Schule Für Medizinische Dokumentation / Marburg / Germany.
What skills is Rainer Richter known for?
Rainer Richter has skills like Ctms, Edc, Klinische Entwicklung, Pharmaindustrie, Gute Klinische Praxis, Ich Gcp, Cro, Onkologie, Life Sciences, Pharmaceutical Industry, Klinische Studien, Clinical Development.
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