Senior Clinical Data Manager managing clinical trial data from start to post lock. Overseeing quality control, timelines, and data entry processes for assigned projects.
Responsibilities
Responsible for managing all aspects of the clinical trial data management process from study start up to post database lock for assigned projects
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
May perform quality control of data entry
Provide input, assess and manage timelines to ensure clinical data management deadlines are met
Develop CRF specifications from the clinical study protocol and coordinate review/feedback from stakeholders
Communicate with study sponsors, vendors and project teams as needed regarding data, database, or other relevant project issues
Requirements
Bachelors and/or a combination of related experience
8+ years’ experience as a Sr. Clinical Data Manager and 5 Years as a Clinical Data Manager II
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
Excellent organizational and communication skills
Professional use of the English language; both written and oral
Experience in utilizing various clinical database management systems
Broad knowledge of drug, device and/or biologic development and effective data management practices
Strong representational skills, ability to communicate effectively orally and in writing
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