Associate Director, GCS Business Technology Solutions

Job Title: Associate Director, GCS Business Technology Solutions

Introduction to role:

Are you ready to make a significant impact in the world of Biopharma Clinical Operations? As an Associate Director in GCS Business Technology Solutions, you'll be at the forefront of driving industry-leading processes, technology, and services. Your role will be pivotal in owning the lifecycle management and continuous improvement of specific clinical operations processes, systems, or services. Collaborate with internal and external stakeholders to ensure customer needs are met and optimize the delivery of clinical studies. You'll identify and deliver improvements using tools like Lean Six Sigma to improve clinical study delivery. Are you up for the challenge?

Accountabilities:

• Design, develop, implement, maintain, continuously improve, and provide ongoing customer support.
• Manage lifecycle of all system documents ensuring compliance with industry regulations and AstraZeneca policies.
• Communicate effectively and timely, providing high-quality training materials.
• Provide training, advice, and end-user support.
• Engage and influence key partners to drive strategy, development, and continuous improvement.
• Understand, evaluate, prioritize, and address customer requirements.
• Supervise performance by defining, tracking, and using key performance indicators for process improvements.
• Support audit and regulatory inspection planning, preparation, and conduct.
• Promote creative and innovative ideas to drive performance and deliver 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, teamwork, problem solving, presentation skills
• Experience in Medidata Rave including iMedidata user and site administration

Desirable Skills/Experience:

• Expert reputation within the business and industry
• Experience using standard process improvement methodologies (e.g. Lean Six Sigma)
• Experience in development and management of Business Processes for performance delivery
• Comprehensive knowledge of ICH/GCP
• Extensive experience in Validation of computerised 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

When we put unexpected teams in the same room, we ignite 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, you'll find yourself in an environment that values transparency and expertise. Here, you can apply your skills across various functions to make decisions that prioritize patients. With a focus on continuous improvement and innovation, you'll be supported by leaders who empower you to work on initiatives that benefit both you and the business. Embrace global opportunities as you supply to research that makes a tangible difference worldwide.

Ready to take on this exciting role? Apply now and become part of our diverse team!