Local Study Associate Director

November 6

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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 according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. • The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. • 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.

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.