Data Integration and Standardization Manager
Location: Wayne, PA Octagon’s novel culture focuses on fostering innovation, encouraging personal growth, and promoting entrepreneurship. Leveraging the experience gained from the successful submission of over 200 NDAs and 500 electronic submissions to the FDA, Octagon continues to lead the industry in data conversion and the implementation of new standards. Our SDTM related experience includes a track record of over 250 studies (3,200 datasets).
Reporting directly to the Director of Data Integration and Standardization within our Clinical Data Operations Department, the Manager’s primary responsibilities will include the following:
- Manage DIS Projects & client deliverables
- Manage a staff of Data Analyst and Developers
- Provide continued mentoring and career development to staff
- Delegate and assign project deliverables
- Assist in interviews and assessments of viable DIS candidates
- Primary contact with Sponsor for all technical issues
- Communicate with project team members to assess progress of project completion
- Train and educate staff on all aspects of data conversion
- Create and maintain data conversion standard operating procedures and guidance documents
- Four-year degree from an accredited college (Life science or Computer science) or equivalent work experience
- Five (5) years data management experience
- Exposure to clinical trial data (preferably 1 - 2 years; phase I, II, III, IV)
- Exposure to SAS data sets (preferred)
- Strong knowledge of database specifications, data analysis of clinical datasets
- Acute attention to detail
- Previous management experience
- Knowledge of data conversion and publishing tools (preferred)
- Experience with data ETL (preferred)
- Understanding of software development in a multi-user environment (preferred)
- Experience handling data sources from heterogeneous systems (preferred)
- Travel Required 10 %
Octagon is an Equal Opportunity Employer with an outstanding corporate culture. Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.
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