Senior Clinical Data Manager

Job Title: Senior Clinical Data Manager

• Provide expertise in data management to support clinical studies performed.
• Assists in the implementation of routine clinical data management activities including discrepancy management, manual data review, data transfers and reporting.
• Assist with authoring of Data Management study plan documents including Data Management Plans (DMP), Data Transfer Plans (DTP) and Data Review Plans (DRP)
• Provide support to Study Lead Data Manager for tracking study progress and identifying issues and risks.
• Assist with data transfers with CROs, SAE/AE reconciliation and thesaurus coding processes.
• Assist with the locking, transfer, and archiving of study databases.

• Minimum 10+ years of experience.
• Minimum 4+ years of Experience with oncology clinical trials.
• A minimum of 3 years of clinical data management experience is also required in the bio/pharmaceutical industry or clinical trials.
• Strong analytical and business communication skills are required
• Experience with Electronic Data Capture (EDC) is required and experience with Interactive Voice or Web Response Systems (IVRS/IWRS) is preferred.
• Expertise in CDISC standards preferred.
• Knowledge of Google Cloud Platform is essential.