Enablement Specialist, eCOA (permanent / 12-months contract)
Enablement drives the delivery of Business Process Excellence and Technology for the Clinical Operations organisation, owning and providing industry leading process, technology and services on behalf of Clinical Operations and its internal and external Partnerships.
The Enablement Specialist is a member of Enablement, and is responsible for the coordination/leading the activities ensuring lifecycle management and business continuity for Clinical Operations processes and tools, performing critical analysis to identify improvements, and developing reports and reporting tools for Clinical Operations systems. Coordinate/lead and deliver Enablement services across drug projects and/or other activities that enable delivery of Clinical Development programs to time, cost, and quality across all delivery models.
eCOA stands for electronic Clinical Outcome Assessment and by definition directly or indirectly measures how patients feel or function and can be used to determine whether or not a drug has been demonstrated to provide a treatment benefit. It measures may provide important patient perspective on the disease and the treatment received; an evaluation that provides clinically important information that is not captured by conventional anti-tumor efficacy data and adverse event reporting.
The Enablement eCOA Specialist is a Co-PM of the project together with vendors PMs, leads all AZ activities such as defining, testing and maintaining the AZ requirements.
1) Operational Activities
As the member of a specific activity team ES:
- Coordinates and delivers Enablement services across drug projects,
- Coordinates life cycle management and business continuity for Clinical 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 Clinical Operations
- Conducts critical analyses of Clinical 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 Clinical Operations.
2) Customer Service and Support:
As the primary point of contact for Clinical Operations Enablement 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 Enablement personnel to drive continuous improvement.
3)Computer SystemValidation Oversight:
Provides guidance and expertise in the planning and delivery of systemvalidation activities (core system and study specific validation), including production and archiving of all computer systemvalidation documentation.
- 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, Clinical Operations Enablement 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.
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.