Site Management & Monitoring Director

The Director Site Management & Monitoring (DSMM) is accountable for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICHGCP as well as relevant local regulations.

The DSMM is responsible for line managing dedicated group(s) of staff and responsible for planning and utilization of staff resources, assigned budget, objective setting and performance follow-up.

It is also expected that the DSMM may contribute to regional/global work tasks as delegated.

As assigned, the DSMM is accountable for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

• Bachelor degree in related discipline,preferably in life science, or equivalentqualification.
• Minimum 5 years of experience in Development Operations (CRA / SrCRA /LSAD) or other related fields.
• Excellent interpersonal skills.
• Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
• Proven project management experience.
• Excellent organisational, analytical, influencing and negotiation skills.
• Excellent presentation and communication skills, verbal and written.
• Line management experience.
• Very good knowledge of the Clinical Study Process and international ICH-GCP guidelines.
• Excellent knowledge of the Monitoring Process.
• Good understanding of the Study Drug Handling Process and the Data Management Process.
• Good knowledge of relevant local and international regulations.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Ability to deliver quality according to the requested standards.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Line management experience.
• Very good knowledge of the Clinical Study Process and international ICH-GCP guidelines.
• Excellent knowledge of the Monitoring Process.

• Good understanding of the Study Drug HandlingProcess and the Data Management Process.
• Good knowledge of relevant local and international regulations.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Ability to deliver quality according to the requested standards.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.