Title: Local Study Associate Director

Location: Field

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. 

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. 

Introduction to the Role:

The Local Study Associate Director (LSAD) leads Local Study Teams at the country level to deliver assigned components of clinical studies according to agreed resources, budgets, and timelines. The LSAD ensures compliance with AstraZeneca procedural documents, international guidelines such as ICH-GCP, and applicable local regulations.

In addition to leading Local Study Teams, the LSAD may perform site monitoring activities as needed to support AstraZeneca’s flexible capacity model. The role is responsible for ensuring that sites are identified, qualified, initiated, monitored, closed, and appropriately documented and archived.

Depending on experience, performance, level of independence, and ability to take on additional responsibilities or mentor junior colleagues, LSADs may be assigned different internal titles, including Local Study Associate Director or Senior Local Study Associate Director. The applicable internal title may be assigned by the Director or Country Head, following confirmation with the appropriate Senior Director, Cluster Head, Executive Director, or Regional Head.

Key Accountabilities

• Has overall responsibility for country-level study commitments and the timely delivery of high-quality data.
• Leads the Local Study Team, including Clinical Research Associates and Clinical Study Associates, for assigned studies.
• Leads and optimizes Local Study Team performance at the country level, ensuring compliance with AstraZeneca procedural documents, ICH-GCP, and applicable local regulations.
• Ensures that clinical and operational feasibility assessments for potential studies are completed to the highest quality.
• Coordinates site selection activities, including identifying potential sites and investigators, completing initial Site Quality Risk Assessments, and conducting Site Qualification Visits.
• Ensures the timely submission of applications and required documents to Ethics Committees and Institutional Review Boards during study start-up and throughout the study.
• Partners with Regulatory Affairs to ensure timely submissions to Regulatory Authorities in accordance with applicable local regulations.
• Ensures the timely preparation of country financial Study Management Agreements and maintains accurate study budgets in AstraZeneca’s clinical study financial systems.
• Conducts regular reviews of financial systems and reports in alignment with the Director of Study Management and Monitoring or Country Head.
• Ensures the timely preparation and maintenance of local Master Clinical Study Agreements, including site budgets and amendments.
• Ensures the timely preparation of country-level Master Informed Consent Forms and site-level consent forms, including required translations and regulatory updates.
• Ensures that all country- and site-level essential documents required under ICH-GCP are collected and verified before sites are authorized to enroll patients.
• Plans and coordinates local investigational product activities, including purchase, reimbursement, distribution, accountability, and destruction.
• Establishes and maintains country-level studies in the Clinical Trial Management System and other systems or websites required by applicable laws and regulations.
• Oversees and coordinates monitoring activities from site activation through study close-out in accordance with approved Monitoring Plans.
• Reviews monitoring visit reports, where required, and provides proactive guidance to monitors on study-related matters.
• Performs co-monitoring, accompanied site visits, and training visits with study CRAs, as required.
• Proactively identifies study risks and facilitates the resolution of complex study issues and problems.
• Organizes regular, agenda-driven Local Study Team meetings.
• Builds and maintains effective working relationships with Local Study Team members, site staff, and global stakeholders.
• Reports study progress, updates, risks, and key issues to the Global Study Associate Director, Global Study Team, and SMM Lead.
• Contributes to patient recruitment strategies and maintains regular communication with participating investigators.
• Develops, maintains, and reviews country-level risk management plans, ensuring that risks are identified, mitigated, and managed proactively.
• Manages relationships with sites, stakeholders, local and global vendors, and other relevant partners.
• Communicates regularly with the National Coordinating Investigator or National Lead Investigator regarding recruitment and other study matters, where applicable.
• Plans and leads National Investigator Meetings in accordance with local requirements and applicable codes.
• Supports forecasting activities related to study timelines, resources, recruitment, budgets, study materials, and investigational product supplies.
• Ensures that systems supporting business-critical and license-to-operate activities, including safety reporting, regulatory submissions, and clinical trial transparency, are established and maintained at the country level.
• Ensures that study-related payments are processed accurately and in accordance with local regulations and agreements.
• Participates in the training and coaching of new Local Study Team members to ensure compliance with ICH-GCP and AstraZeneca procedural documents.
• Ensures the completeness of the electronic Trial Master File and the timely filing of essential documents to maintain inspection readiness.
• Ensures that all study documents are prepared for final archiving and completion of the local portion of the electronic Trial Master File.
• Plans and leads activities associated with audits and regulatory inspections in collaboration with Clinical Quality Assurance and Quality Assurance teams.
• Provides input into process development and continuous improvement initiatives.
• Provides regular updates to country-level Line Managers regarding study progress, planned milestones, and key issues.
• Keeps Line Managers informed about CRA and CSA performance.
• Ensures that country-level study activities comply with local policies, applicable codes of ethics, and AstraZeneca requirements.
• Provides feedback on research-related information, including site, investigator, and competing-study insights that may be relevant to the local market.
• Ensures compliance with AstraZeneca’s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and Safety, Health and Environment.
• Collaborates with the local Medical Affairs team.
• Supports local, regional, and global Study Management and Monitoring initiatives as agreed with SMM Line Management.
• Performs CRA-specific activities in accordance with the applicable CRA Job Description.
  

Essential Skills and Experience

• Bachelor’s degree in a relevant discipline, preferably in life sciences, or an equivalent qualification.
• A minimum of three years of experience in Development Operations, such as a Clinical Research Associate or Senior Clinical Research Associate role, or in related areas, including Medical Affairs-led or academic-led studies.
• Strong knowledge of international ICH-GCP guidelines and applicable local regulations.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials on or ahead of schedule, within budget, and to the required quality standards.
• Excellent project management skills.
• Excellent team-building and interpersonal skills.
• Excellent organizational skills.
• Excellent verbal and written communication skills.
• Ability to prioritize effectively and manage multiple tasks.
• Excellent attention to detail.
• Excellent spoken and written English-language skills.
• Effective negotiation skills.
• Ability to learn and adapt to new information technology systems.
• Willingness and ability to travel nationally and internationally, as required.
  

Where Can I Find Out More?

Learn more about AstraZeneca and our opportunities by following us on social media:

• LinkedIn: Follow AstraZeneca Careers.
• Facebook: Follow AstraZeneca Careers.
• Instagram: Follow AstraZeneca Careers.
• YouTube: Explore AstraZeneca’s U.S. footprint and scientific innovation.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.