Statistical Methodology Data Scientist enhancing research methodologies at Roche. Supporting decision - making through expert guidance and collaboration with various teams in clinical research.
About the role
- 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
- Strong leadership and interpersonal skills
- Ability to undertake occasional travel.
Benefits
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation
- Discretionary annual bonus
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