Roles and Responsibilities:
Position: This position is for handling (1) training activities, (2) preparing/updating SOPs and checking compliance, (3) documentation, (4) QC activities.
- Be an Internal Quality Control (IQC) representative to handle the SOP training of the team.
- Set the SPARC QMS (Quality Management System) workflow for the training.
- Maintain the training files of Clinical science team members.
- Update the skill matrix/ organograms, and coordinate the process of updating the JD/training files per the SOP.
- Update/prepare training files of the team.
- Prepare/update/circulate SOPs for review and self-familiarization
- Coordinate SOP review and training.
- Review documents and internal processes for SOP compliance.
- Prepare/update and evaluate the SOP questionnaires.
- Maintain a tracker of comments/suggestions from stakeholders on the SOP for the process improvement.
Maintain trackers of MW documents including protocols, IB, ICF, CSR, CT registry.
QC: MW-QC of the clinical trial documents including review/formatting
Apply through this Link