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Company

AstraZeneca · 6 hours ago

Local Study Associate Director

Wilmington, DE

Full-time

Remote

Mid Level

3+ years exp

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BiopharmaBiotechnology

Comp. & Benefits

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Responsibilities

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.

Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies

Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.

Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.

Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.

Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.

Ensures timely preparation of country financial Study Management Agreement and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.

Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.

Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.

Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).

Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.

Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.

Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices the monitor(s) on study related matters.

Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.

Proactively identifies risks and facilitates resolution of complex study problems and issues.

Qualification

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HematologyCell TherapyICH-GCPEnglish LanguageDevelopment OperationsProject Management

Required

Bachelor degree in related discipline, preferably in life science

Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies)

Good knowledge of international guidelines ICH-GCP as well as relevant local regulations

Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality

Excellent project management skills

Excellent team building and interpersonal skills

Excellent organisational skills

Excellent verbal and written communication skills

Excellent ability to prioritize and handle multiple tasks

Excellent knowledge of spoken and written English

Must Have Experience In Hematology Or Cell Therapy

Company

AstraZeneca

Glassdoor

4.1

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

Founded in 1999

Cambridge, Cambridgeshire, GBR

10,001+ employees