Director, Site Management & Monitoring
Short 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 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.
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.
In some countries a DSMM may also take responsibilities as Local Study Associate Director (LSAD) or Clinical Quality Associate Director (CQAD) if required and agreed with the (Senior) Director, Country Head.
- 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 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 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
- 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.
- 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.
- 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.
(*) to be adapted to local country market needs.
- 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.
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.