Local Study Associate Director

AstraZeneca

About The Position

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. The role may also include site monitoring activities to support AstraZeneca’s flexible capacity model. It is responsible for ensuring sites are identified, qualified, initiated, monitored, closed, and appropriately documented and archived. Depending on experience, performance, independence, and ability to take on additional responsibilities or mentor colleagues, the role may be assigned the internal title of 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 or regional leadership. The position has overall responsibility for country-level study commitments and timely delivery of high-quality data. It leads and optimizes Local Study Team performance, oversees country and site study operations, supports recruitment and risk management, maintains inspection-ready study documentation, and coordinates with local and global stakeholders. The role also supports audits, regulatory inspections, continuous improvement, and Study Management and Monitoring initiatives.

Requirements

Bachelor’s degree in a relevant discipline, preferably life sciences, or equivalent qualification.
At least three years of experience in Development Operations, such as a Clinical Research Associate or Senior Clinical Research Associate role, or 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 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.

Responsibilities

Lead Local Study Teams, including Clinical Research Associates and Clinical Study Associates, for assigned studies.
Manage country-level study commitments and ensure timely delivery of high-quality data within agreed resources, budgets, and timelines.
Ensure compliance with AstraZeneca procedures, ICH-GCP, applicable local regulations, local policies, and codes of ethics.
Ensure high-quality clinical and operational feasibility assessments for potential studies.
Coordinate site selection, including identifying potential sites and investigators, completing initial Site Quality Risk Assessments, and conducting Site Qualification Visits.
Ensure timely Ethics Committee and Institutional Review Board submissions during study start-up and throughout the study.
Partner with Regulatory Affairs to ensure timely submissions to Regulatory Authorities.
Prepare country financial Study Management Agreements and maintain accurate study budgets in clinical study financial systems.
Review financial systems and reports with the Director of Study Management and Monitoring or Country Head.
Prepare and maintain local Master Clinical Study Agreements, site budgets, and amendments.
Prepare and maintain country-level Master Informed Consent Forms and site-level consent forms, including translations and regulatory updates.
Ensure essential country- and site-level documents required under ICH-GCP are collected and verified before sites are authorized to enroll patients.
Plan and coordinate local investigational product activities, including purchase, reimbursement, distribution, accountability, and destruction.
Establish and maintain country-level studies in the Clinical Trial Management System and other systems or websites required by law and regulation.
Oversee and coordinate monitoring from site activation through close-out according to approved Monitoring Plans.
Review monitoring visit reports where required and provide proactive guidance to monitors.
Perform co-monitoring, accompanied site visits, and training visits with study CRAs as required.
Identify study risks proactively and facilitate resolution of complex study issues.
Organize regular, agenda-driven Local Study Team meetings.
Build and maintain effective relationships with team members, site staff, global stakeholders, vendors, and other partners.
Report study progress, updates, risks, and key issues to the Global Study Associate Director, Global Study Team, and SMM Lead.
Contribute to patient recruitment strategies and maintain regular communication with participating investigators.
Develop, maintain, and review country-level risk management plans and ensure risks are identified, mitigated, and managed proactively.
Communicate with the National Coordinating Investigator or National Lead Investigator about recruitment and other study matters where applicable.
Plan and lead National Investigator Meetings in accordance with local requirements and applicable codes.
Support forecasting for study timelines, resources, recruitment, budgets, study materials, and investigational product supplies.
Ensure country-level systems supporting safety reporting, regulatory submissions, and clinical trial transparency are established and maintained.
Ensure study-related payments are processed accurately and in accordance with local regulations and agreements.
Train and coach new Local Study Team members on ICH-GCP and AstraZeneca procedures.
Ensure the electronic Trial Master File is complete and essential documents are filed in a timely manner to maintain inspection readiness.
Prepare study documents for final archiving and completion of the local portion of the electronic Trial Master File.
Plan and lead audit and regulatory inspection activities with Clinical Quality Assurance and Quality Assurance teams.
Contribute to process development and continuous improvement initiatives.
Update country-level Line Managers on study progress, planned milestones, and key issues; keep them informed about CRA and CSA performance.
Provide feedback on research-related information, including site, investigator, and competing-study insights relevant to the local market.
Comply with AstraZeneca’s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and Safety, Health and Environment.
Collaborate with the local Medical Affairs team.
Support local, regional, and global Study Management and Monitoring initiatives as agreed with SMM Line Management.
Perform CRA-specific activities in accordance with the applicable CRA Job Description.