Local Study Associate Director

November 7

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AstraZeneca

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Pharmaceutical • Biopharmaceutical • Innovation • Research and development • Global business

10,000+

💰 Post-IPO Debt on 2023-02

Description

• To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies • Responsible to ensure that sites are identified, qualifications performed, set up, initiated, monitored, closed and documentation archived. • Overall responsibility for the study commitments within the country and timely delivery of data to required quality. • Leads and optimizes performance of the Local Study Team(s) ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations. • Ensures timely submission of application/documents to EC/IRB at start up and duration of the study. • Coordinates site selection process by identifying potential sites/investigators and conducting Site Qualification Visits. • Ensures timely preparation of country financial Study Management Agreement and maintains accurate study budget. • 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 monitoring activities from site activation through to study closure.

Requirements

• Minimum Requirements • 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.