Edgar A.
Manager Data Management @Julius Clinical
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WORK HISTORY
Manager Data Management @Julius Clinical
Coordinates the activities of the Data Management team for the clinical projects, identifies capacity problems in respect of the individual and team workload and allocates resources to clinical projects;• Represents data management in internal and external study teams;• Keeps oversight on relevant data management activities across projects, as specified in the Data Management Plan;• Coaches and supports the Data Managers (Level 1-3) on project related tasks;• Writes and updates Data Management related SOPs, WIs and quality documents and ensures the implementation of latest data quality requirements;• Works with the IT department in validating the computerized clinical study management systems;• Contributes to process improvements, e.g. professionalization of work activities, methods of reporting, implementation of new legislation and regulations;• Creates Data Management services cost proposals;• Acts as line manager for direct reports, including team goal setting, coaching and support teammembers with personal development goals;
EDUCATION
Yerevan State University
Bachelor of Art, International Relations and Diplomacy
Deutsche Akademie
German Language
ABOUT EDGAR A.
STRENGTHS / PERSONAL SKILLS:• Highly motivated professional with 21 years experience in Clinical Data Management• Certified Rave and IBM Database Builder/Designer• Awareness of applicable regulatory rules and guidelines: e.g. ICH, GCP• Handling pressure at work by efficient planning• Effectively organize and plan tasks• Good interpersonal relation establishment and maintenance at work place• Escalating issues as required• Excellent verbal and written communication skills• Willingness to take additional responsibilities at any time of tenure• Able successfully working in a (virtual) team environment• Professional knowledge of Clinical Trial/Data Management Systems• Offer support and constructive feedback to project team members• Seek opportunities to develop experience and knowledge • High sense of responsibility and urgency in completing assignments• Meticulous attention to detail• Show commitment and perform consistently high quality workTHERAPEUTIC EXPERIENCE:Cardiovascular OsteoporosisGenitourinary System Overactive BladderEndometriosisUterine FibroidsBenign prostatic hyperplasiaAllergy and Respiratory System AsthmaPulmonary Arterial HypertensionUncomplicated acute otitis mediaCOVID-19 Musculoskeletal System Knee OsteoarthritisActive Idiopathic Inflammatory MyopathyNeurology Bipolar II DisorderAlzheimer’s DiseaseCerebral IschemiaAnxiety DisordersMultifocal Motor NeuropathyMetabolismType 2 Diabetes MellitusAnti-Invectives HIVHepatitis С / HCV GT1b OncologyUnresectable Locally Advanced Metastatic Thyroid CancerUntreated Unresectable or Metastatic NSCLCRecurrent or Metastatic Squamous Head and Neck CancerHER2 positive early breast cancerEpidermal Growth Factor Receptor (EGFR) Non-small Cell Lung CancerOtorhinolaryngology Diffuse Otitis Externa Acute Sinusitis/Rhinosinusitis Hematology Von Willebrand disease Urology Benign Prostatic Hyperplasia Inflammatory SpondyloarthritisTransplantologyKidney and Liver
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