- Job description
Required Software Tool Competencies:
Basic office tools (e.g. MS Suite); CDMS (e.g. Medidata Rave, Oracle Clinical, INFORM etc..); J-Review; SAS programming will be a plus.
• 5 to 7 years of extensive experience as Study Set-Up Clinical Data Management
• Experience negotiating with and influencing others to meet challenging goals. Must be self-motivated, with the ability to follow through on assignments without direct supervision, very attentive to detail, capable at multitasking across projects and able to effectively contribute in a team environment.
• Experience working with vendors who supply clinical data in electronic format.
• Strong analytical skills to facilitate detecting and resolving data problems encountered in clinical research studies
• Demonstrates a strong understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project.
Responsible for data management review to lock activities of assigned protocols and independently overseeing database update process.
• Responsible for proactively identifying and resolving issues noted during data management which impact the overall timelines and informs the appropriate Client team members (e.g. Clinical Site Managers, Site Monitor, Medical Encoders, eClinical Support & Submissions, Data Leads, Global Pharmacovigilance) and coordinates follow-up.
• Assists with vendor relations (e.g., CRO; CCL) as needed to support the incumbent’s project(s), e.g., participation in monthly vendor meetings to discuss project issues.
• Responsible for the development of data review plan and processes for data management that can be easily accessible by all Study Set-Up team members.