Director, Site Management & Monitoring

Location: Barcelona, Spain (On-site) 3 days/week working from the office.

The Director, Site Management & Monitoring (DSMM) is responsible for ensuring the successful performance and management of the assigned team, guaranteeing the successful delivery of all clinical interventional studies under the supervision of a Country Head, in accordance with agreed resources, budgets, and timelines. All study activities must comply with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations.

This role oversees a dedicated group or groups of staff, taking accountability for line management, resource planning and utilization, budget oversight, objective setting, and performance monitoring.

The DSMM is also expected to contribute to regional and global initiatives as delegated, providing support to the Country Head as needed. In this role, the DSMM ensures that their team guarantee study site identification, conduct site qualifications and that sites are set up, initiated, monitored, and properly closed, with all study documentation appropriately archived.

Typical Accountabilities

• Lead a dedicated team, fostering a cohesive team spirit and shaping a positive, high-performing team culture and professional behaviours.

• Ensure that the team is adequately staffed and that all studies under their supervision are adequately resourced to achieve successful and efficient outcomes, in alignment with (Senior) Director, Country Head.

• Balance and monitor team workload, ensuring assignments are distributed appropriately among direct reports.

• Oversee the development and performance management of direct reports, supporting their growth and effectiveness.

• Ensure that every direct report has an up-to-date development and training plan aligned with the Individual Development Plan (IDP) process.

• Provide ongoing coaching and mentorship to direct reports, arranging additional external coaching opportunities when required.

• Prepare salary and bonus recommendations for direct reports based on performance, in close collaboration with the (Senior) Director, Country Head, and local HR Business Partner.

• Collaborate with the (Senior) Director, Country Head to ensure efficient operations and effective organizational functioning of Site Management & Monitoring (SMM) activities at the country level

• Contribute expertise to high-quality feasibility assessments for clinical studies.

• Oversee the achievement of SMM study delivery targets at the country level, ensuring timely completion with a strong focus on quality, in alignment with (Senior) Director, Country Head.

• Support continuous improvement of study-related processes and procedures to drive quality outcomes.

• Ensure all required systems are consistently maintained and updated for optimal operation.

• Oversee the completeness and timeliness of the electronic Trial Master File (eTMF), ensuring it remains "Inspection Ready".

• Assist the (Senior) Director, Country Head and/or Local Study Associate Directors (LSADs) and study teams in forecasting key elements of clinical studies, including timelines, resources, recruitment, study materials, and drug supply.

• Provide direction and guidance to LSADs and study teams on major study deliverables, proactively addressing and resolving priority issues. • Support regional SMM initiatives and activities, as needed, in partnership with the (Senior) Director, Country Head.

• Foster strong collaboration with the local Medical Affairs team to ensure functional alignment and compliance.

• Ensure all study operations at the country level conform to local policies and the company’s code of ethics.

• Ensure regulatory tasks and start- up activities related to the studies assigned to the country are accomplished.

• Review and evaluate accompanied site visits, co-monitoring visits, training visits, and Quality Control (QC) visits performed for direct reports, according to local QC plans.

• Conduct accompanied site visits per the local QC plan, using this opportunity to support coaching and continuous development of team members.

• Participate in local regulatory or operational external expert groups as necessary at the country level

Education, Qualifications, Skills and Experience

Education and experience: Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders. Previous experience in the pharmaceutical industry, preferably in Clinical Operations.

Relevant knowledge and ability to fulfil key responsibilities, including but not limited to: Drug development process and related GxP processes, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including monitoring, study drug handling and data management.

Role-Required Skills:

• Personal Effectiveness & Drives Accountability in Others

• Learning Agility

• Financial, Technology & Process Competency

• Active Listening, Fluency in written & spoken business-level English

• Act with Integrity & high ethical standards • Effective and adaptive team leadership, including cross-functional, virtual and global environments & demonstrate cultural awareness

• Identify and champion more efficient delivery of quality clinical trials with optimised cost and time • Ability to travel nationally/internationally as required

• Valid driving license, if country employment requirement

• Communication & Teamwork - Influencing, Collaboration, Business Acumen

• Scientific Concept & Research Design - Applying Disease and TA knowledge, Industry Awareness

• Effective, risk-based thinking – Problem Solving, Critical Thinking, Decision Making • Deliver Priorities Results & Impact - Recruitment/Retention Planning & Action, Ensures Accountability, Empowerment & Delegation, Cultivates Innovation, Delivers Results

• Leadership – Enable Change, Feedforward & Coaching, Drives Engagement & Development, Building Effective Teams, Manages Conflict.

Date Posted

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.