Clinical Operations Lead Manager

• 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.
• 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 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 key issues identified.
• Supports SMM region in initiatives/activities as agreed with (Senior) Director, 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.

Education, Qualifications, Skills and Experience Essential

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification ().
• Minimun 3 years as Clinical Project Manager or similar.
• 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.
• Ensures all systems are continuously updated.

Excellent organisational, analytical, influencing and negotiation skills.

• Excellent presentation and communication skills, verbal and written.
• Excellent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT systems.
• Ability for national and international travel.

Desirable 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.

• Ability to work in an environment of remote collaborators.
• Integrity and high ethical standards.
• Good resource management skills.
• Excellent decision-making skills.
• Good financial management skills.
• Good conflict management skills and ability to handle crisis.
• Good interviewing skills – responsibility for attracting, developing and retaining personnel.
• Excellent team building skills also in cross-functional teams.
• Good intercultural awareness.
• Excellent ability to work according to global standards.