Manager, GCS Business Technology Solutions
Manager, GCS Business Technology Solutions
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Job Description
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 youll 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:
- Bachelors 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. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 worlds 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!
Date Posted
13-Jun-2025Closing Date
21-Jun-2025AstraZeneca 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.
Required Experience:
Manager
Employment Type
Full-Time
