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.

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 authorisation and employment eligibility verification requirements.