Local Study Associate Director

AstraZeneca•Wilmington, NC

63d

About The Position

Are you ready to take on a pivotal role in clinical study management? As a Local Study Associate Director (LSAD) at AstraZeneca, you'll lead Local Study Teams to ensure the successful delivery of country-level study commitments. You'll manage clinical studies with precision, adhering to AstraZeneca's procedural documents, international guidelines like ICH-GCP, and local regulations. Reporting to either the Director Country Head or Director Site Management & Monitoring, you'll 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.

Requirements

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 (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.
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

Responsibilities

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 contributors—for 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.