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!