Local Study Associate Director Biopharma

Introduction to role

Are you ready to lead and inspire? As a Local Study Associate Director, you'll spearhead Local Study Teams at the country level, ensuring the delivery of clinical study components with precision and efficiency. Your leadership will be pivotal in adhering to AstraZeneca's procedural documents, international guidelines like ICH-GCP, and local regulations. In addition to leading teams, you may engage in site monitoring to support our flexible capacity model. You'll be responsible for site identification, qualification, setup, initiation, monitoring, closure, and documentation archiving. Your experience level will determine your internal title, reflecting your years of experience, performance record, and ability to mentor junior colleagues.

Accountabilities

Your role is crucial in ensuring study commitments are met within the country and delivering high-quality data on time. You will lead Local Study Teams, optimize their performance, and ensure compliance with AZ Procedural Documents, ICH-GCP, and local regulations. You'll coordinate site selection, manage submissions to regulatory bodies, maintain study budgets, and oversee drug activities. Your proactive approach will identify risks and resolve complex study issues. You'll foster strong relationships with team members and stakeholders, contribute to patient recruitment strategies, and ensure systems are set up for critical activities. Your leadership will guide audits and regulatory inspections while providing input for process improvement.

Essential Skills/Experience

- Recent experience in clinical trial coordination tasks in the Oncology field over the past year
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*)
- Minimum 3 years of experience in Development Operations (CRA, SrCRA) 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 attention to details
- Excellent knowledge of spoken and written English
- Good negotiation skills
- Good ability to learn and to adapt to work with IT systems
- Ability to travel nationally and internationally as required

Desirable Skills/Experience

- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas
- Good knowledge of the Drug Development Process
- Excellent understanding of the Clinical Study Process including monitoring
- Very good understanding of the Study Drug Handling Process and the Data Management Process
- Integrity and high ethical standards
- Good analytical skills
- Good resource management skills
- Good decision making and delegation skills
- Good financial management skills
- Basic change management skills
- Basic coaching skills
- Basic ability in handling crisis situations
- Good intercultural awareness

AstraZeneca is a place where innovation thrives! We are committed to transforming healthcare by harnessing digital technology, data, and analytics. Our forward-thinking mindset drives us to disrupt the status quo and create meaningful change in predicting, preventing, and treating patients' conditions. We foster creativity and collaboration, building global partnerships that empower us to deliver improved outcomes beyond core medical solutions. Join us in shaping the future of healthcare with a team that values diverse perspectives and lifelong learning.

Ready to make an impact? Apply now to join AstraZeneca's journey towards revolutionizing healthcare!

Date Posted

04-dic-2025

Closing Date

01-ene-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.