Roles and Responsibilities:

Position: This position is for handling (1) training activities, (2) preparing/updating SOPs and checking compliance, (3) documentation, (4) QC activities.

Training coordination:

• 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.

SOP:

• 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.

Documentation:

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