Local Study Associate Director

Local Study Associate Director

Introduction to role

Are you ready to take on a pivotal role in clinical study management As a Local Study Associate Director (LSAD) at AstraZeneca youll lead Local Study Teams to ensure the successful delivery of country-level study commitments. Youll manage clinical studies with precision adhering to AstraZenecas procedural documents international guidelines like ICH-GCP and local regulations. Reporting to either the Director Country Head or Director Site Management & Monitoring youll collaborate with the Global Study Team to drive study success. Your leadership will extend beyond team management as you may also engage in site monitoring activities ensuring study sites are effectively identified qualified and monitored throughout the study lifecycle.

Accountabilities

• Hold overall responsibility for fulfilling country-level study commitments and ensuring timely high-quality data delivery.

• Lead the Local Study Team(s)comprising Clinical Research Associates (CRAs) Clinical Study Administrators (CSAs) and other contributorsfor assigned studies fostering collaboration and high performance

• Drive optimal performance and compliance of Local Study Team(s) with AstraZeneca Procedural Documents ICH-GCP requirements and local regulations.

• Ensure the highest quality in the clinical and operational feasibility assessment of potential studies as required.

• Coordinate and oversee the site selection process identifying potential sites and investigators conducting initial site quality risk assessments and when necessary performing Site Qualification Visits to evaluate suitability and quality risk.

• Ensure timely submission of required applications and documentation to Ethics Committees/IRBs and in partnership with Regulatory Affairs supports the delivery of study submissions to Regulatory Authorities in line with local regulations.

• Prepare accurate country-level financial agreements and maintain up-to-date study budgets within the clinical financial system ensuring regular checks and alignment with input from the Director SMM or Director Country Head and Clinical Finance reporting function as appropriate.

• Ensure the set-up and ongoing management of studies within CTMS electronic Trial Master File (eTMF) study finance systems and any other tools or local platforms necessary to meet country-specific laws and requirements.

• Oversee manage and coordinate all monitoring activities from site activation to closure in accordance with Monitoring Plans and thoroughly review monitoring visit reports offering support and guidance to monitors.

• Conduct required co-monitoring visits accompanied site visits and training visits with study CRAs to ensure quality and consistency.

• Proactively identify risks facilitate the swift resolution of complex study problems and escalate as necessary.

• Organize and lead regular agenda-driven Local Study Team meetings fostering transparent communication and teamwork.

• Build and maintain positive relationships with Local Study Team members site staff and global stakeholders to ensure smooth study delivery.

• Report study progress and updates to the Global Study Associate Director Global Study Team and SMM/Study Operations Lead as applicable.

• Contribute to patient recruitment strategies and maintain regular contact with investigators to support enrolment goals.

• Develop maintain and review a study-level country risk management plan managing sites stakeholders vendors and customers to ensure timely risk identification and mitigation.

• Coordinates closely with National Coordinating Investigator or National Lead Investigator on recruitment and other study matters when applicable.

• Plans and leads National Investigator Meetings in alignment with local codes as needed.

• Assists with forecasting for study timelines resource needs recruitment budgeting materials and investigational product supply.

• Ensures set-up updating and access to business-critical systems for activities such as Safety Reporting Regulatory Submissions and Clinical Trial Transparency at the country level.

• Ensure accuracy and compliance of all study payments adhering to local regulations and agreements.

• Participate in the training and coaching of new Local Study Team members ensuring quality and adherence to ICH-GCP standards and AstraZeneca procedures.

• Maintain the study eTMF in an Inspection Ready state ensuring documentation is complete and current.

• Plan and lead audit and regulatory inspection activities working with the Clinical Quality Associate Director (CQAD) and Quality Assurance teams.

• Contribute insights for process development and ongoing improvement within the organization.

• Keep line managers regularly informed about study status milestones key issues and team performance.

• Ensure full compliance with local policies codes of ethics and business practices in all study-related activities.

• Provide feedback on research trends competing studies or site/investigator information that can benefit the local market.

• Collaborate with the local Medical Affairs team as needed for optimal study delivery and scientific quality.

• Actively support SMM initiatives at the local regional or global level as agreed with line management.

Essential Skills/Experience
Education and experience:

• Bachelors 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.

• 0 years experience in the pharmaceutical industry preferably in Clinical Operations (CRA SrCRA) or other related fields (Medical Affairs-led or Academic-led studies)

• 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 project management 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 Effectively lead a team across in-person and virtual settings to deliver shared goals demonstrates 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 Impactful Site conversations Effective risk-based thinking Plans & Aligns Strategic thinking Problem Solving Critical Thinking Decision Making Effective Issue Management Clinical Study Operations (GCP) & Quality Management - RbQM: Interpreting and implementing the Monitoring Plan Study site selection & set-up Deliver Priorities Results & Impact - Project Management Recruitment/Retention Planning & Action.

Why AstraZeneca

At AstraZeneca youll be part of a dynamic team tackling some of the most complex challenges in medicine development. With access to extensive capabilities and a comprehensive pipeline youll be involved in countless submissions across various therapy areas. Our fast-paced environment encourages innovation and experimentation. We value dedication and couragequalities that drive us forward even when facing unknowns. Here youll find an inspiring learning environment where setbacks are seen as opportunities for growth. Join us in making a profound impact on patients lives through research that truly matters.

Ready to make a difference Apply now!

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