Clinical Research Associate

The responsibilities of the Clinical Research Associate at AstraZeneca involve ensuring the execution of Study Delivery processes by developing study reports tools, facilitating the study delivery system, and maintaining the system. As an expert in the field, you will be responsible for ensuring the delivery of a centrally managed study management service across clinical studies from start-up to reporting. Your role will also involve serving as the main contact and collaborating closely with the Document Management group until the Clinical Study Report is finalized. In addition, you will be responsible for initiating and maintaining the production of study documents, ensuring template and version compliance, as well as creating or importing clinical-regulatory documents into the Global Electronic Library according to the Global Document List. Collaboration with Data Management Center or Data Management Enablement representatives to facilitate the delivery of study-related documents will also be a part of your responsibilities. Managing and coordinating the tracking of study materials and equipment, monitoring administrative tasks during the study process, audits, and regulatory inspections according to company policies are also key aspects of the role. As a Clinical Research Associate, you will act as a technical owner within Patient Safety, demonstrating a deep understanding of processes and internal regulations. It is essential to keep your knowledge of best practices and new relevant developments up to date. Liaising with compliance team members to improve regulatory processes within the team and identifying opportunities to enhance the methodology and provide practical solutions for clinical development are also important responsibilities. Regarding People Management Responsibility, this role does not involve direct or indirect reports. The global remit for this position is limited to the own country. The ideal candidate for this position should possess a Bachelor's degree in a relevant discipline, experience in Study Management within a pharmaceutical or clinical background, and knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management. Desirable qualifications include an advanced degree within the field, professional certification, and an understanding of multiple aspects within Study Management. Key relationships to reach solutions include internal interactions with the Study management function and other AstraZeneca employees, as well as external collaborations with external service providers and regulatory bodies. AstraZeneca is committed to creating an inclusive and diverse team representing all backgrounds and perspectives, with a focus on industry-leading skills. The company values diversity and equality of opportunity and welcomes applications from all qualified candidates, irrespective of their characteristics. AstraZeneca complies with all applicable laws and regulations on non-discrimination in employment and recruitment, as well as work authorization and employment eligibility verification requirements.,