Senior Clinical Data Manager
hace 3 semanas
Position Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.
Essential functions of the job include but are not limited to:
Qualifications:
Minimum Required:
Other Required:
8+ years’ experienceProficiency in Microsoft Office: Word, Excel, PowerPoint, OutlookAble to handle a variety of clinical research tasksExcellent organizational and communication skillsProfessional use of the English language; both written and oralExperience in utilizing various clinical database management systemsBroad knowledge of drug, device and/or biologic development and effective data management practicesStrong representational skills, ability to communicate effectively orally and in writingStrong leadership and interpersonal skillsAbility to undertake occasional travelPreferred:
Experience in a clinical, scientific or healthcare disciplineDictionary medical coding (MedDRA and WHODrug)Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)Oncology and/or Orphan Drug therapeutic experience-
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