Functional Process Owner EMR2EDC Global Clinical Solutions Technologies

AstraZeneca•Durham, NC

10d

About The Position

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Requirements

Bachelor of Science (BSc) in a relevant discipline or equivalent experience.
Extensive experience in Drug Development within a pharmaceutical or clinical environment.
Strong business process, technology and clinical study information knowledge.
Strong operational knowledge of system processes in the clinical trial setting.
Demonstrated project management capabilities with a track record of delivering to time, cost and quality.
Ability to work collaboratively, motivate and empower others to meet individual, team and organizational objectives.
Experience in vendor management, working collaboratively with external partners for mutual benefit.
Excellent written and verbal communication, influencing, negotiation, collaboration, problem‑solving, presentation, mentoring and interpersonal skills.

Nice To Haves

Recognized expert reputation within the business and/or industry.
Experience using standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes and drive process optimization.
Experience in the development and management of business processes to enhance performance.
Comprehensive knowledge of ICH/GCP.
Extensive experience in validation of computerized systems in a regulated environment (preferably pharmaceutical), including validation documentation (plans, reports, test scripts) and knowledge of GxP, SOX and related requirements.
Strong experience with Quality Systems and Quality Management, including process definition and improvement, ideally within an Information Systems context.
Experience planning and implementing EMR2EDC middleware systems for clinical trials, including project management activities with study teams and/or sites.
Experience with Medidata Rave, including iMedidata user and site administration, report administration, core configuration, study build and edit check programming.

Responsibilities

Own the full lifecycle (design, development, implementation, maintenance and continuous improvement) of assigned Development Operations system processes.
Develop and maintain high‑quality guidelines, user manuals, training materials, templates and toolkit documents.
Provide expert advice, training and end‑user support on system processes and supporting documentation.
Define, track and monitor KPIs for the allocated processes, using data to identify improvements and support cross‑functional optimization.
Deliver Corrective and Preventive Actions (CAPA) to time and quality, acting on trends identified through Quality & Risk Management.
Escalate risks and issues as required and support risk mitigation strategies.
Ensure customer requirements are understood, critically evaluated, prioritized and addressed, providing clear rationale where needs cannot be met.
Engage and influence internal and external stakeholders to drive process strategy, development and continuous improvement.
Liaise with Process Owners, BPMO, Governance representatives and System Owners to ensure alignment with SOPs, higher‑level processes and system procedures.
Provide input to BPMO and Process Owners on new SOPs and regulations affecting the process.
Be an active member of relevant Governance Teams.
Support audit and regulatory inspection planning, preparation and conduct.
Promote creative and innovative ideas to drive performance and deliver new solutions for customers.
Act as the primary point of contact for Development Operations GCS system processes within Study Teams.
Understand the system processes, technologies and services used by Study Teams, including their needs and pain points, to provide guidance, remove barriers and identify improvement opportunities.
Ensure effective resolution of system process issues that impact study delivery, engaging the appropriate process, technology and service experts and leveraging escalation routes and governance bodies.
Share lessons learned and best practices with Study Teams and GCS colleagues to foster continuous improvement.