The Clinical Data Manager will be responsible with leading all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets.
- Mentor, train and supervise junior associates as needed in clinical data management processes and procedures
- Independently lead a number of complex trials
- Lead CRF design, review and validation of clinical database, including management of CRO activities in this area as assigned if required
- Be responsible for creation of data management plans and other data management documentation as needed
- Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines partnering as appropriate with Clinical Operations, Franchise and other BSDM functions
- Lead, coordinate, facilitate and manage all data management activities from initiation of protocol through database lock, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects
- Proactively organize and manages ongoing data review throughout study conduct, including being responsible for the correction of errors and discrepancies management for the life of a project
- Proactively identify and address issues that may impact the quality of the data, deliverables or timelines
- At least 10 years of clinical data management experience in Pharmaceuticals is required.
- Experience of successful active participation in cross-functional teams is preferred.
- Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software is required.
Sthree US is acting as an Employment Business in relation to this vacancy.