Local Study Associate Director

Role Purpose

The Local Study Associate Director (LSAD) is responsible for leading Local Study Teams (LSTs) at the country level to deliver clinical study commitments on time, within budget, and in compliance with AstraZeneca Procedural Documents, ICH‑GCP, and local regulations.

In addition to leadership responsibilities, the LSAD may perform site monitoring activities to support flexible resourcing. The LSAD ensures successful site identification, qualification, initiation, monitoring, closure, and documentation archiving.

Key Responsibilities

Study Leadership

• Lead Local Study Teams (CRAs, CSAs) for assigned studies and ensure high‑quality delivery of country-level commitments.

• Oversee study execution in accordance with AZ standards, ICH‑GCP, and local regulations.

• Maintain strong communication and collaboration with global study leadership and stakeholders.

• Drive timely delivery of high‑quality data and achievement of study milestones.

Study Feasibility & Start‑Up

• Perform and/or oversee operational and clinical feasibility assessments.

• Coordinate site selection, including identification, Site Quality Risk Assessment, and Site Qualification Visits.

• Ensure timely submissions to Ethics Committees/IRBs and regulatory authorities.

• Prepare and maintain study budgets (country fSMA), site budgets (Master CSA), and Informed Consent Forms (Master ICF & localised versions).

• Verify that all essential documents are collected and validated prior to site activation.

Study Conduct & Oversight

• Oversee site monitoring activities from activation to closure according to the Monitoring Plan.

• Review monitoring visit reports and provide guidance to CRAs.

• Conduct co‑monitoring, accompanied visits, or training visits as required.

• Ensure study‑related systems (CTMS, local websites) are accurate and up to date.

• Manage local drug‑related activities (procurement, reimbursement, destruction).

• Lead Local Study Team meetings and maintain strong working relationships with sites and stakeholders.

Risk Management & Issue Resolution

• Develop and maintain country‑level risk management plans.

• Identify risks early and drive effective issue resolution.

• Collaborate with National Coordinating/Lead Investigators as applicable.

• Contribute to patient recruitment strategies and site engagement.

Financial & Administrative Oversight

• Ensure accuracy and timeliness of payments and budget management.

• Oversee license‑to‑operate requirements (e.g., safety reporting, clinical trial transparency).

• Provide regular progress updates to Line Managers and Global Study Teams.

• Share insights regarding investigator/site performance and competing studies when relevant.

Quality, Compliance & Inspection Readiness

• Maintain an “inspection‑ready” eTMF with timely document upload and completeness checks.

• Ensure readiness for audits and regulatory inspections; lead country-level preparation.

• Support process improvement initiatives at local, regional, or global levels.

• Ensure compliance with AstraZeneca’s Code of Ethics, policies, and local legislation.

Training & Team Support

• Provide training, onboarding, and coaching for new LST members.

• Support performance reviews and feedback for CRAs/CSAs.

• Collaborate with Medical Affairs and support SMM initiatives as agreed.

People Management

• Direct reports: 0

• Indirect reports: 10–15 (average, within study teams)

• Operates primarily as a matrix manager at project level.

• Scope may include own country or small multi‑country clusters.

Education, Skills & Experience

Essential

• Bachelor’s degree in life sciences or equivalent education.

• Minimum 3 years of Development Operations experience (CRA, Sr CRA) or related field (e.g., academic‑ or MA‑led studies).

• Strong knowledge of ICH‑GCP and local regulatory requirements.

• Proven ability to lead and motivate cross‑functional teams.

• Excellent project management, organizational, and communication skills.

• Strong interpersonal and team‑building capabilities.

• Ability to handle multiple priorities with attention to detail.

• Proficiency in written and spoken English.

• Strong negotiation and problem‑solving skills.

• Ability to quickly learn and adapt to new IT systems.

• Willingness to travel nationally and internationally.