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.
Qualifications:
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.