Director, Site Management and Monitoring
AstraZeneca
- Taiwan
- Permanent
- Full-time
- Leadership of dedicated group, building the team spirit, developing team style and behavior.
- Ensures adequate resources for the studies assigned.
- Ensures that the workload of direct reports is adequate.
- Development and performance management of direct reports.
- Ensures that direct reports have development and training plans, according to IDP process.
- Coaches the direct reports on a regular basis, and plans/organizes coaching with external providers if needed.
- Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible CH/CD SMM and local HRBP.
- Contributes to efficient SMM organization and its functioning at country level by working closely with responsible CH/CD SMM.
- Contributes to high quality feasibility work if applicable.
- Oversees successful delivery of SMM study delivery country level targets to plan, with speed and quality.
- Contributes to the quality improvement of the study processes and other procedures.
- Ensures all systems are continuously updated.
- Ensures completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
- Assists CH/CD SMM or LSAD/teams in forecasting study timelines, resources, recruitment, study materials and drugs.
- Provides direction to LSAD/teams on major study commitments including resolving any key issues identified.
- Supports SMM region/global in initiatives/activities as agreed with CH/CD SMM.
- Ensures collaboration with local Medical Affairs team and global stakeholders.
- Ensures that study activities at country level comply with local policies and code of ethics.
- Reviews SQV reports of direct reports in line with AZ SOPs
- Reviews Accompanied site visits/co- monitoring visits/training visits/QC visits performed to direct reports in line with the local QC plans.
- Performs accompanied site visits according to local QC Plan, supporting ongoing coaching and development
- Bachelor’s of Science in an appropriate discipline
- Extensive experience in Study Management within a pharmaceutical or clinical background
- Thorough knowledge of Study Management processes and local regulations
- Excellent communication and relationship building skills
- Advanced degree in a scientific discipline
- Expert reputation within the business and industry
- Extensive knowledge of the latest technical and regulatory expectations