Clinical Site Lead

Responsibilities

• Drive clinical trial site performance and enhance investigator engagement within assigned disease areas in Japan.
• Proactively manage recruitment performance and ensure strong oversight of Contract Research Organizations (CROs).
• Contribute to operational feasibility assessments and provide strategic input on recruitment and retention strategies.
• Develop and implement risk mitigation and contingency plans to ensure site management and monitoring activities meet agreed timelines.
• Lead and manage activities related to site selection, patient recruitment strategies, and SMO management.
• Oversee the quality of clinical study data and manage queries or quality issues in collaboration with CRAs.
• Provide strategic input to clinical study documents, including protocols, informed consent forms, and monitoring plans.

Requirements

• At least 3 years of experience in the pharmaceutical industry or a Clinical Research Organization (CRO), preferably in Clinical Operations (CRA or Senior CRA).
• Bachelor's degree in a related discipline, preferably in life sciences, or an equivalent qualification.
• Demonstrated leadership capability within a team environment.
• Proven ability to negotiate complex issues or requirements with site staff.
• Strong communication, teamwork, and influencing skills.
• Ability to work flexibly and respond quickly to shifting clinical trial demands.

Preferred Qualifications

• Experience collaborating with external partners.
• Direct experience performing monitoring activities from qualification visits through to site closure.

About the Company

AstraZeneca is a leading, forward-thinking BioPharmaceutical company dedicated to delivering life-changing medicines. We foster a culture of collaboration and innovation, working as one team to help patients all over the world.