Manager, GCS Business Technology Solutions

Job Title: Manager, GCS Business Technology Solutions

Career Level: D

Introduction to role:

Are you ready to lead and innovate in the realm of Biopharma Clinical Operations? As a Manager in GCS Business Technology Solutions, you'll be at the forefront of designing, developing, and continuously improving processes, systems, and services that drive clinical study delivery. Collaborate with internal and external stakeholders to meet customer needs and enhance the efficiency of clinical studies. Utilize tools like Lean Six Sigma to identify and implement improvements, ensuring optimal end-to-end delivery. Are you prepared to make a difference?

Accountabilities:

• Design, development, implementation, maintenance, continuous improvement, and ongoing customer support.
• Lifecycle management of all system documents, ensuring compliance with industry regulations and AstraZeneca policies.
• Effective communication of information and provision of high-quality training materials.
• Provide training, advice, and end-user support.
• Engage and influence key partners to drive strategy, development, and continuous improvement.
• Keep EDC User Accesses updated and oversee periodic reviews.
• Perform EDC Platform Level Activities for new study setups.
• Support audit and regulatory inspection planning, preparation, and conduct.
• Deliver Corrective and Preventive Actions timely and act on data or trends identified through Quality & Risk Management.
• Promote creative and innovative ideas to drive performance and bring new solutions to customers.

Essential Skills/Experience:

• Bachelor’s of Science in an appropriate subject area or equivalent experience.
• Extensive knowledge of Drug Development within a pharmaceutical or clinical background.
• High level of business process, technology, and Clinical Study information experience.
• Demonstrated project management skills to deliver to time, cost, and quality.
• Ability to collaborate with, motivate, and empower others to accomplish objectives.
• Experience working successfully with external partners delivering mutual benefit.
• Excellent written, verbal, influencing skills; negotiation, collaboration, problem-solving, presentation, mentoring, conflict management, interpersonal skills.
• Experience in Medidata Rave including iMedidata user/site administration, report administration, core configuration, study build/edit check programming.

Desirable Skills/Experience:

• Expert reputation within the business and industry.
• Experience applying standard process improvement methodologies (e.g., Lean Six Sigma).
• Experience in development/management of Business Processes for business performance.
• Comprehensive knowledge of ICH/GCP.
• Extensive experience in Validation of computerized systems in a regulated environment.
• Extensive experience of Quality Systems and Quality Management.
• Medidata Study Builder certification.
• Experience in other EDC systems (e.g., Veeva, Bioclinica).
• Experience in other Medidata products including Rave EDC, Site Cloud, Medidata Coder.
• Experience working within agile environment using JIRA.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are driven by curiosity and courage to explore the possibilities of science. Our commitment to making a difference fuels our passion for innovation as we work towards treating some of the world's most complex diseases. By fusing data and technology with scientific advancements, we aim to achieve breakthroughs that impact billions of lives globally. Join us in an inclusive environment where collaboration with academia and industry pioneers new approaches to healthcare.

Ready to make an impact? Apply now to join our team!

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.