The Enablement Specialist is a member of GCS, and is responsible for the coordination/leading the activities ensuring lifecycle management and business continuity for Development Operations processes and tools, performing critical analysis to identify improvements, and developing reports and reporting tools for Development Operations systems. Coordinate/lead and deliver GCS services across drug projects and/or other activities that enable delivery of Clinical Development programs to time, cost, and quality across all delivery models.

Typical Accountabilities:

1) Operational Activities

As the member of a specific activity team ES:

• Coordinates and delivers GCS services across drug projects.
• Coordinates life cycle management and business continuity for Development Operations processes, systems/tools, standards, procedural documentation and training materials.
• Provides expert support to user communities including:
  • conducting relevant process/system/tool trainings,
  • facilitating knowledge sharing,
  • establishing of best practice,
  • ensuring communication within Development Operations.
• Conducts critical analyses of Development Operations processes and tools to define business usage and identify opportunities to improve efficiency/effectiveness of systems/methods/processes; Define and develop User Requirement Specifications and User Acceptance Tests.
• Maintains an awareness of the trends/changes in the external clinical process and technology environment to identify opportunities for improvement; participate in the evaluation and assessment of new technologies.
• Contributes to and/or develops business cases for continuous improvement project.
• Participates in change initiatives relating to Development Operations.

2) Customer Service and Support:

As the primary point of contact for Development Operations GCS processes, technology and services within a Study Team:

• Understands the processes, technology and services the study team relies on, their needs and pain points. Uses this knowledge to provide advice and guidance, removes barriers, provides solutions and identifies opportunities for improvement.
• Ensures the effective resolution of process, technology and service risks and issues that impede the Study Teams progress and effective delivery. Identifies and engages with the right process, technology and service experts, and expertly utilises escalation routes and governance bodies to gain traction and deliver rapid solutions.
• Shares lessons learned and best practice recommendations with the Study Team and with GCS personnel to drive continuous improvement.

3) Computer System Validation Oversight:

Provides guidance and expertise in the planning and delivery of system validation activities (core system and study specific validation), including production and archiving of all computer system validation documentation.

Essential qualifications:

• University degree in related discipline, preferably in biological science or healthcare-related fields, such as medicine, nursing or sanitary engineering, or equivalent experience in the aforementioned disciplines.
• At least 2 year experience in Drug Development within a pharmaceutical or clinical background.
• Understanding of the clinical study and drug development process and ICH GCP guidelines in relation to study delivery operational activities.
• Ability to work collaboratively; proven organizational and analytical skills, and proven skills to deliver to time, cost and quality.
• Computer proficiency.
• Excellent knowledge of spoken and written English.
• Communication skills, knowledge sharing and problem-solving approach.
• Any Project and Vendor management skills would be an advantage.

In return, Processes and Enabling Solutions will offer a strong career development opportunity for the successful candidate.  We are committed to develop the role of Enablement Specialist and equip its incumbents with a strong training program and supporting network to help them progress to the next level.

Date Posted

Closing Date

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.