Careers
Senior Clinical Data Manager
King of Prussia, PA
job responsibilities included, but are not limited to:
- Serves as the primary contact for internal team members regarding clinical data management data review activities and leads these review activities to ensure delivery of data fit for analysis.
- Provides input into clinical system development activities, to ensure systems support the data review needs of the study, focusing on critical data and processes, and identified risks.
- Ensures clinical data management review requirements are put into production per the study’s protocol risk evaluation and integrated data review plan (IDRP)
- Contributes to the development and maintenance of study plans documents specifying data review strategy and applicable procedures on assigned protocols/projects.
- Develops and oversees the timelines of clinical data management activities during the life cycle of studies.
- Communicates and triages issues to appropriate roles for follow-up and action to address root cause.
- Leads clinical data management activities on projects with diverse scope.
- Leads and hosts the data monitoring meetings, communicating issues to the internal and external stakeholders in a meaningful way such as summarizing the data and representing the information visually.
- Use high level knowledge of the protocol, identifies critical data and processes from protocol review, and supports protocol risk evaluation process.
- Coordinates with assigned project teams to communicate, address and resolve data related issues and recommends potential solutions; escalates issues which potentially impact patient safety or study analysis.
- Trains and mentors new and less experienced team members
- Participates in CRO and/or third-party audits as required
- Develops and maintains data review study documentation as appropriate to facilitate data validation and analytics.
Additional Qualifications are:
SAS Training
- Intro to SAS® System Course
- SAS® Fundamentals Course
- SAS® Programming Course
- SAS® Report Writing Course
- SAS® Advanced Techniques and Efficiencies Course
- SAS® Macro Course
- SAS® SQL Course
- Using SAS/STAT® for Applied Statistics Course
- Using SAS/GRAPH® Course