Director Site Management and Monitoring

**Director Site Management and Monitoring (SMM), EU - Study Start-up Clinical Trial Regulation (CTR)**
**Locations: Across Europe where we have an SMM presence**
**Competitive salary and benefits**

The Site Management & Monitoring (SMM) team is facing an exceptional opportunity. We are about to embark on the journey on implementing EU CTR into our daily work. Do you want to lead this new ways of working and re-invent our organisation to find new and more effective ways of working in delivering our studies? _Are you seeing opportunities in change and get motivated by trying new ways? We need you, come be a part of our journey_

SMM is part of the Development Operations in the global Research & Development (R&D) function. SMM executes and delivers clinical studies. The clinical studies are delivered in close collaboration with stakeholders in health care and academic medical institutions. Our teams work flexible and are based in many countries throughout Europe. The **Director SMM (DSMM**) will be located in one of our SMM EU country location and will report into SMM Europe.

The 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. An important part will be the responsibility for line managing EU CTR Part 2 coordinator group(s) of staff and responsibility for planning and utilization of staff resources, assigned budget, objective setting, development plans and performance follow-up.
**The role**:
As DSMM you will in this role ensure that the EU/EEA study start-up is efficient and fully compliant and that clear processes and responsibilities are developed and maintained. In start-up and during the study you will assure that your team of EU CTR Part 2 coordinators become key players in the study submission and approval phase. A great part of the role will be to develop and manage procedures, planning timelines and oversee quality. You will also manage and mentor a dedicated group - building the team spirit, developing team style and behavior. You will be responsible for the development and performance management of direct reports, ensure that the workload of direct reports is adequate and make sure that direct reports have development and training plans.

**Main responsibilities**:

- Oversees successful delivery of SMM EU/EEA study submission and approval targets to plan, with speed and quality.
- Contributes to the quality improvement of the study start-up processes with focus on the EU CTR and Part 2 Coordination as well as other procedures. Supports SMM EU region in initiatives/activities as agreed.
- Performs quality activities, supporting ongoing coaching and development.
- Line manager and team leader of the Part 2 Coordinators team accountable for people development, resource planning and allocations.

**Essential requirements**:

- Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification.
- Minimum 5 years of experience in Clinical Operations (CRA / Sr. CRA / LSM) or other related fields.
- Excellent knowledge and recent experience of EC submissions, site start-up procedures, eTMF and archiving requirements.
- Line management experience and excellent interpersonal skills.
- Proven experience in clinical process development and maintenance.
- Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
- Great organisational, analytical, influencing and negotiation skills.
- Excellent knowledge of spoken and written English - both presentation and communication skills, verbal and written.
- Ability for national and international travel.

**Desirable requirements**:

- Excellent knowledge of the clinical study process and international ICH-GCP guidelines.
- Excellent knowledge of quality oversight including quality control procedures.
- Good knowledge of relevant local and international regulations.
- Ability to deliver quality according to the requested standards and ability to work according to global standards.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Ability to work in an environment of remote collaborators and proven team building skills also in cross-functional teams.