AstraZeneca

Job Description

Role description:

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.

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 (Senior) Director, Country Head and local HRBP.
• Contributesto 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 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 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.

Skills

• 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.
• Good ability to learn and to adapt to work with IT systems.
• Ability for national and international travel.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.

Qualifications

• Education: Bachelor degree in related discipline, preferably in life science, or equivalent qualification
• Language: Excellent knowledge of spoken and written English.
• Work Experience:
• Minimum 5 years of experience in Development Operations (CRA / SrCRA / LSAD) or other related fields.
• Minimum 1 year of experience in Team Management
• Competencies: Social intelligence, emotional intelligence conflict management, interpersonal skills, learning agility, decision-making, being a good coach, courage

Date Posted

21-2월-2024

Closing Date

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 authorization and employment eligibility verification requirements.