Local Study Associate Director

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. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

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 optimises 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 (fSMA) 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.

Education & Experience Requirements:

Minimum Requirements

Bachelor degree in related discipline, preferably in life science and

• 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.

Required Skills

• • 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.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

The annual base salary for this position ranges from $136,364 - 204,546.00

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) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with 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. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

09-Apr-2025

Closing Date

15-Apr-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.