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AstraZeneca · 1 day ago

Local Study Associate Director

Wilmington, DE

Full-time

Onsite

Lead/Staff, Director/Executive

$136K/yr - $204K/yr

5+ years exp

AstraZeneca is a global biopharmaceutical company that focuses on the discovery and development of innovative medicines. As a Local Study Associate Director, you will lead Local Study Teams to ensure compliance with clinical study protocols and local regulations while managing all aspects of study execution from initiation to closure.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

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

Qualification

Study ManagementICH-GCP complianceClinical study deliverySite QualificationPatient Safety processesRegulatory complianceProject managementRisk managementStakeholder managementTeam leadership

Required

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

Preferred

Advanced degree within field

Professional certification

Clinical study delivery operational experience

Project management experience

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.

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees