Support (Sr.) Project manager / (Asso.) Project Management Director on Clinical projects to sets up, monitor and report in accordance with ICH/GCP, the company’s requirements and the local/regional regulation to achieve clinical operation and study target on timeline, quality and cost.
- Participates in the development of clinical trial documents in collaboration with the project manager.
- Identifies and selects investigators/sites in collaboration with the project manager.
- Prepares / collects all documents needed prior to study initiation.
- Performs study feasibility visits in the investigational sites.
- Organizes / participates in study site initiation visit in which are provided scientific and technical knowledge concerning the study procedures and its organisation.
- Ensures monitoring follow up:
- Maintain the relationship with the investigational site.
- Follow up of trial progress and quality control of data (source document check).
- Documentation of protocol violations, adverse events and premature treatment cessation.
- Identification and resolution of all problems: logistical, methodological, human technical, which occur during the trial.
- Management of the local trial files.
- Management of the investigator’s trial file.
- Management of trial related logistics.
- Detection and reporting of deviations, finding and implementing corrective measures.
- Provides timely monitoring reports for all visits / contacts in appropriate reports.
- Performs study close out visits to close investigational site.
- Prepares, organizes and participates in investigator’s meetings.
- Manage study TMF filing and archiving.
- Participates in internal & external education and training.
- Bachelor’s degree and above.
- Major in clinical medicine, pharmacy and biology or relevant.
- Have 2 years of relevant monitoring experience in clinical trial, and have knowledge reserve of clinical trial management specification (GCP).
- Strong communication and coordination skills with internal /external clients.
- Strong team spirit, sense of responsibility, proactive, careful and meticulous.
- Good computer skills, including proficiency in Microsoft Word, Excel and PowerPoint.
- Good oral and written communication skills.
- Good organization and problem-solving skills.
- Have a talent with effective time management.