Local Study Associate Director

AstraZeneca

9d • $136,000 - $204,000 • Remote

About The Position

As a Local Study Associate Director, you'll spearhead Local Study Teams (LSTs) to deliver critical components of clinical studies, ensuring compliance with AZ Procedural Documents, international guidelines like ICH-GCP, and local regulations. In addition to leading LSTs, you may also perform site monitoring to support our flexible capacity model. Your role will be pivotal in identifying sites, performing qualifications, and ensuring seamless study execution from initiation to closure. You will: • Take full responsibility for study commitments within the country and ensure timely delivery of high-quality data. • Lead Local Study Teams consisting of CRAs and CSAs for assigned studies. • Optimize team performance at the country level, ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations. • Conduct clinical and operational feasibility assessments of potential studies with precision. • Coordinate site selection by identifying potential sites/investigators and conducting Site Qualification Visits. • Ensure timely submission of applications/documents to EC/IRB and Regulatory Authority throughout the study. • Prepare and maintain accurate study budgets and agreements in AZ clinical studies financial system. • Develop country-level Master Informed Consent Forms and ensure compliance with AZ SOPs and local regulations. • Collect and verify trial essential documents prior to study start, ensuring sites are ready to enroll. • Plan and coordinate local drug activities, from purchase to destruction. • Manage monitoring activities from site activation to study closure in accordance with Monitoring Plans. • Review monitoring visit reports and advise monitors on study-related matters. • Identify risks and resolve complex study problems proactively. • Organize regular Local Study Team meetings with a focus on collaboration. • Report study progress to the Global Study Associate Director/Global Study Team. • Contribute to patient recruitment strategy and communicate regularly with Investigators. • Develop risk management plans at the country study level and manage stakeholders effectively. • Lead National Investigator meetings as required. • Forecast study timelines, resources, recruitment, budget, materials, and drug supplies. • Ensure systems for business-critical activities are set up and updated at the country level. • Ensure accurate payments related to the study are performed according to regulations. • Train and coach new Local Study Team members in compliance with ICH-GCP and AZ Procedural Documents. • Maintain eTMF "Inspection Ready" status by uploading essential documents timely. • Lead activities associated with audits and regulatory inspections in liaison with CQAD and QA. • Provide input for process development and improvement. • Update Line Managers on study milestones/key issues and CRA/CSA performance. • Ensure compliance with AstraZeneca’s Code of Ethics, policies, and procedures.

Requirements

• Bachelor’s degree in relevant discipline.
• A Minimum of five(5) years of experience in Study Management within a pharmaceutical or clinical background.
• Thorough knowledge of Patient Safety processes and local regulations.

Nice To Haves

• Advanced degree within field.
• Professional certification.
• Clinical study delivery operational experience.
• Project management experience.

Responsibilities

• Take full responsibility for study commitments within the country and ensure timely delivery of high-quality data.
• Lead Local Study Teams consisting of CRAs and CSAs for assigned studies.
• Optimize team performance at the country level, ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations.
• Conduct clinical and operational feasibility assessments of potential studies with precision.
• Coordinate site selection by identifying potential sites/investigators and conducting Site Qualification Visits.
• Ensure timely submission of applications/documents to EC/IRB and Regulatory Authority throughout the study.
• Prepare and maintain accurate study budgets and agreements in AZ clinical studies financial system.
• Develop country-level Master Informed Consent Forms and ensure compliance with AZ SOPs and local regulations.
• Collect and verify trial essential documents prior to study start, ensuring sites are ready to enroll.
• Plan and coordinate local drug activities, from purchase to destruction.
• Manage monitoring activities from site activation to study closure in accordance with Monitoring Plans.
• Review monitoring visit reports and advise monitors on study-related matters.
• Identify risks and resolve complex study problems proactively.
• Organize regular Local Study Team meetings with a focus on collaboration.
• Report study progress to the Global Study Associate Director/Global Study Team.
• Contribute to patient recruitment strategy and communicate regularly with Investigators.
• Develop risk management plans at the country study level and manage stakeholders effectively.
• Lead National Investigator meetings as required.
• Forecast study timelines, resources, recruitment, budget, materials, and drug supplies.
• Ensure systems for business-critical activities are set up and updated at the country level.
• Ensure accurate payments related to the study are performed according to regulations.
• Train and coach new Local Study Team members in compliance with ICH-GCP and AZ Procedural Documents.
• Maintain eTMF "Inspection Ready" status by uploading essential documents timely.
• Lead activities associated with audits and regulatory inspections in liaison with CQAD and QA.
• Provide input for process development and improvement.
• Update Line Managers on study milestones/key issues and CRA/CSA performance.
• Ensure compliance with AstraZeneca’s Code of Ethics, policies, and procedures.

Benefits

• A qualified retirement program [401(k) plan]
• Paid vacation, holidays, and paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans.
• Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
• The annual base salary for this position ranges from $136,000 to $204,000 However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
• In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees