Director, Site Management and Monitoring

DSMM is accountable for delivering the committed part of oncology and and haematology clinical interventional studies under their supervision according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

Typical Accountabilities

• 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

Requirement

Essential

• 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

Desirable

• Advanced degree in a scientific discipline
• Expert reputation within the business and industry
• Extensive knowledge of the latest technical and regulatory expectations

Date Posted

23-Jan-2025

Closing Date

02-Jul-2025

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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