Short Role Description

To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines, complying with AZ Procedural Documents, international guidelines such as ICH-GCP, as well as relevant local regulations.

In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model.

The LSAD is responsible for ensuring that sites are identified, qualified, set up, initiated, monitored, closed, and properly archived.

LSADs may have different internal titles based on experience level (LSAD, Senior LSAD). The experience level depends on:

• Years of experience
• Performance record
• Level of independence
• Ability to take on additional tasks or tutor junior colleagues

This internal title may be assigned by the Director, Country Head Senior Director, Country Head after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head.

Typical Accountabilities

• Overall responsibility for study commitments within the country and timely delivery of quality data.
• Leads Local Study Team (CRA(s), CSA(s)) for assigned studies.
• Optimises LST performance ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations.
• Ensures high‑quality feasibility assessments for potential studies.
• Coordinates site selection, including initial Site Quality Risk Assessment and Site Qualification Visits.
• Ensures timely EC/IRB submissions and supports Regulatory Affairs with regulatory submissions.
• Prepares country financial Study Management Agreement (fSMA) and maintains accurate budgets.
• Prepares local Master CSA (including site budgets) and amendments.
• Prepares country Master ICF (MICF) and local site ICFs, including translations.
• Ensures essential documents are collected and verified prior to study start.
• Plans and coordinates local drug activities (purchase, reimbursement, destruction).
• Sets up and maintains CTMS and relevant local websites.
• Oversees monitoring activities from activation to closure, ensuring alignment with Monitoring Plans.
• Reviews monitoring visit reports and advises CRAs.
• Performs co‑monitoring and accompanied visits as needed.
• Identifies risks proactively and resolves complex issues.
• Organises LST meetings and fosters strong team relationships.
• Reports study progress to GSAD/GST including SMM Lead.
• Contributes to recruitment strategies and communicates with investigators.
• Develops and reviews country‑level risk management plans.
• Coordinates with National Coordinating Investigator / National Lead Investigator (if applicable).
• Plans and leads National Investigator Meetings.
• Supports forecasting (timelines, recruitment, resources, budget, supplies).
• Ensures systems for safety reporting, submissions and transparency are properly set up and updated.
• Ensures accurate payments according to local regulations and agreements.
• Participates in onboarding, training and coaching of new LST members.
• Ensures eTMF completeness and “Inspection Ready” status.
• Prepares documents for final archiving and eTMF completion.
• Supports audits and inspections with CQAD and QA.
• Provides input for process development and improvement.
• Updates Line Managers on studies, milestones and CRA/CSA performance.
• Ensures compliance with local policies and codes of ethics.
• Provides feedback on research information relevant to the local market.
• Ensures compliance with AZ Code of Ethics and policies (people, finance, technology, security, SHE).
• Collaborates with Medical Affairs.
• Supports SMM in local, regional, or global initiatives.

For CRA activities, refer to CRA Job Description.

People Management Responsibility

• Direct reports: 0
• Indirect reports: 10–15 (on average)
• Role type: Individual contributor / Matrix Manager (projects/dotted line)

Span of Influence:
Operates in own country or small clusters (2–3 countries).

Education, Qualifications, Skills and Experience

Essential

• Bachelor’s degree in related discipline (preferably life sciences) or equivalent.
• Minimum 3 years of experience in Development Operations (CRA/SrCRA) or related fields.
• Recent experience in clinical trial coordination tasks on Oncology field minimum over the past 1,5 years
• Strong knowledge of ICH‑GCP and local regulations.
• Proven ability to lead cross‑functional teams delivering on time, budget, and quality.
• Excellent project management, organisational, interpersonal and communication skills.
• Ability to prioritise, handle multiple tasks and maintain attention to detail.
• Strong English (spoken/written).
• Good negotiation skills and ability to learn IT systems.
• Ability to travel nationally/internationally.

Desirable

• Good medical knowledge and ability to learn relevant AZ therapy areas.
• Knowledge of Drug Development Process and Clinical Study Process.
• Understanding of Drug Handling Process and Data Management.
• Integrity and ethical standards.
• Analytical, resource management, decision‑making and financial management skills.
• Basic skills in change management, coaching, and crisis handling.
• Good intercultural awareness.

Key Stakeholders and Relationships

Internal

• Local Study Team
• Global Study Team including SMM Lead (STOM)
• Line Manager / local SMM LT
• Clinical Quality Associate Director
• Medical Affairs and MSLs
• Regulatory Affairs
• Patient Safety

External

• Investigators and site staff
• Vendors and partners involved in study conduct