AstraZeneca is looking to fill the role of Associate Director Clinical Research (ADCR) to lead and manage a team responsible for the successful delivery of clinical interventional studies, ensuring adherence to high standards and international regulations.
Requirements
- 4+ years of Clinical Research Associate (CRA) or monitoring experience
- Previous experience in the pharmaceutical industry, preferably in Clinical Operations (CRA / SrCRA / LSAD) or other related fields.
- Relevant knowledge and ability to fulfill key responsibilities, including but not limited to: Drug development process and related GxP processes, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including project management, monitoring, study drug handling and data management.
Responsibilities
- Oversee the entire lifecycle of study site management, from identification to closure, ensuring excellence at every step.
- Contribute expertise to high-quality feasibility assessments, supporting appropriate site and study selection.
- Support the achievement of country-level SMM study delivery targets, ensuring studies are delivered to plan with both speed and quality.
- Drive quality improvement of study processes and procedures, championing best practices and continuous enhancement.
- Maintain all required systems in an up-to-date state to support efficient and compliant study conduct.
- Ensure the electronic Trial Master File (eTMF) is kept complete, accurate, and “Inspection Ready”.
- Provide direction and support to CRAs and CSAs on major study deliverables and proactively resolve key issues.
Other
- Provide leadership to a dedicated team, fostering team spirit and cultivating a positive, high-performing team climate and professional behavior.
- Ensure adequate resourcing for all assigned clinical studies, enabling the team to efficiently meet study objectives.
- Regularly monitor and balance the workload of direct reports, ensuring fair distribution and manageable assignments.
- Oversee the development and performance management of direct reports, guiding them toward continuous growth and success.
- Ability to travel nationally/internationally as required
