Local Study Associate Director · Site Management & Monitoring

Fri, 24 Apr 2026 14:18:06 GMT

Site Management & Monitoring · Wilmington, Delaware, United States of America

The Local Study Associate Director leads the delivery of country-level clinical study commitments, guiding Local Study Teams to meet agreed timelines, budgets and quality standards. This role works in close alignment with Global Study Teams and local leadership to ensure that studies are designed, set up, conducted, and closed in full compliance with AstraZeneca Procedural Documents, ICH-GCP and local regulations.

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Accountabilities

Hold overall accountability for meeting country-level study commitments, ensuring timely delivery of high-quality data.

Lead Local Study Teams for assigned studies, including CRAs, CSAs and other contributors, promoting collaboration, clarity of roles and strong performance.

Drive optimal performance and compliance of Local Study Teams with AstraZeneca Procedural Documents, ICH-GCP requirements and local regulations.

Oversee high-quality clinical and operational feasibility assessments for potential studies, providing robust input into study selection and design.

Coordinate and manage the site selection process, including identification of potential sites and investigators, initial site quality risk assessments and, where needed, Site Qualification Visits to assess suitability and quality risk.

Ensure timely submission of applications and documentation to Ethics Committees/IRBs and, in partnership with Regulatory Affairs, support delivery of submissions to Regulatory Authorities in line with local requirements.

Prepare accurate country-level financial agreements and maintain current study budgets within the clinical financial system, working closely with Director SMM or Director Country Head and Clinical Finance as appropriate.

Ensure effective set-up and ongoing management of studies within CTMS, eTMF, study finance systems and any other tools or local platforms required by country-specific laws and processes.

Oversee, manage and coordinate all monitoring activities from site activation to closure according to Monitoring Plans, reviewing monitoring visit reports and providing guidance and support to monitors.

Conduct co-monitoring visits, accompanied site visits and training visits with study CRAs to drive quality, consistency and development.

Proactively identify risks, facilitate rapid resolution of complex study issues and escalate when necessary.

Organize and lead regular, agenda-driven Local Study Team meetings that enable transparent communication, issue resolution and aligned decision-making.

Build and maintain strong working relationships with Local Study Team members, site staff and global stakeholders to support smooth study execution.

Report study progress, milestones, risks and mitigation plans 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 targets.

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

Coordinate closely with National Coordinating Investigator or National Lead Investigator on recruitment and other key study matters where applicable.

Plan and lead National Investigator Meetings in line with local codes when required.

Support forecasting for study timelines, resource needs, recruitment, budgeting, materials and investigational product supply.

Ensure set-up, updating and access to business-critical systems for Safety Reporting, Regulatory Submissions and Clinical Trial Transparency at country level.

Ensure accuracy and compliance of all study payments in accordance with local regulations and agreements.

Participate in training and coaching of new Local Study Team members to ensure quality delivery and adherence to ICH-GCP and AstraZeneca procedures.

Maintain the study eTMF in an inspection-ready state at all times, ensuring documentation is complete, accurate and current.

Plan and lead audit and regulatory inspection activities in collaboration with the Clinical Quality Associate Director and Quality Assurance teams.

Contribute insights to process development and continuous improvement initiatives across 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 and site/investigator insights that can inform local strategy.

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

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

Essential Skills/Experience

Bachelor’s degree in related discipline with 5+ years of previous experience in the pharmaceutical industry

Relevant knowledge and ability to fulfill 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 optimized 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

Desirable Skills/Experience

Bachelor's degree in the life sciences field is preferred

Previous experience in Clinical Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies) is a plus