Director, Site Management & Monitoring

at  AstraZeneca

REQUIREMENTS:

• Bachelor degree in related field, preferably in life science, or equivalent qualification (*).
• 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 contribute to business.
• Proven project management experience.
• Excellent organisational, analytical, influencing and negotiation skills.
• Excellent presentation and communication skills, verbal and written.

COME AND JOIN OUR AZ TEAM WHERE YOU WILL PLAY A PIVOTAL ROLE IN THIS EXCITING PERIOD OF DEVELOPMENT!

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 aligning with AZ Procedural Documents, international guidelines such as ICH-GCP 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.
As assigned, the DSMM is accountable for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

KEY RESPONSIBILITIES:

• Leadership of dedicated group, building the team spirit, developing team style and behaviour.
• 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/organises coaching with external providers if needed.
• Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible (Senior) Director, Country Head and local HRBP.
• Contributes to efficient SMM organisation and its functioning at country level by working closely with responsible (Senior) Director, Country Head.
• 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 (Senior) Director, Country Head or Local Study ADs/ Local Study Teams in forecasting study timelines, resources, recruitment, study materials and drugs.
• Provides direction to LSAD/ Local Study Teams on major study commitments including resolving any
• Ensures collaboration with local Medical Affairs team.
• Ensures that study activities at country level align 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.