Primary Responsibilities
As a member of the team in our Global Business Solutions (GBS) center, responsible for managing and reviewing and filing study documents that are used on clinical trials. This position is also responsible for written and verbal correspondence with the internal team as well as regulatory authorities, ethics committees, investigators, monitors, and sponsors.
Specific Responsibilities
- At all times, complies with SGS Code of Integrity and Professional Conduct.
- Responsible for maintaining the filing system and managing the central study documentation (TMF/ISF)
- Assists in the development of study documents and study submission.
- Assists with written and verbal correspondence with regulatory authorities, ethics committees, investigators, monitors, and sponsors Assists in the reviewof study documents.
- Assist with the development and updating of SOPs, Work Instructions, and training material related to study paperwork creation.
- Supports collaboration with external service providers (e.g., hospitals, laboratories)
- Ensure compliance with regulations.
- Provides excellent customer service to clients and maintains positive interaction with peers and supervisors.
- Adheres to internal standards, policies, and procedures.
- Performs other duties as assigned by the project manager or team lead.
- Performs other related duties as may be assigned either in support of departmental goals or for his/her personal or professional training, education or development as programmed by his/her immediate superior.
- Ensures work area in GBS is kept clean and presentable at all times.
- Remains familiar with SGS quality assurance procedures.
- Complies to all SGS health and safety and HR policies and procedures.
