Director, Site Management & Monitoring

Typical Accountabilities

• 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 Country Head and local HRBP.

• Contributes to efficient SMM organisation and its functioning at country level by working closely with responsible Country Head.

• Contributes to high quality feasibility work.

• 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 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

key issues identified.

• Supports SMM region in initiatives/activities as agreed with Country Head.

• Ensures collaboration with local Medical Affairs team.

• 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.

Requirements:

Essential

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification

• Minimum 5 years of experience in Development Operations (CRA / SrCRA / LSAD) or other related fields.

• Minimum 2 years of line management experience.

• 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.

Desirable:

• 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.