DPS (eCOA) Implementation Scientists in Global Clinical Solutions

Location: Warsaw

Hybrid work - 3 days in office, 2 remote per week

Global Clinical Solutions (GCS) drives the delivery of services and technology for AstraZeneca for its internal and external stakeholders.

GCS Digital Patient Solution (DPS) Service is accountable for DPS Technology implementation in AZ studies, from DPS requirements gathering, through project management of whole DPS Technology delivery according to study needs and timeliness. DPS Technology is understood as electronic Clinical Outcome Assessments and any connected devices to eCOA app, collecting data directly from patients.

Including patient voice in drug development is important therefore AZ develops strategies to measure meaningful aspects of the patient experience including symptoms, health status and health-related quality of life in our studies. The DPS implementation Scientist will play a crucial role in the implementation of these strategies, providing combined implementation and scientific view on eCOA implementation and DPS technology development.

The role is dedicated to AZ BioPharma Portfolio, focusing on CardioVascular, Renal and Metabolic (CVRM) and Respiratory (RIA) therapeutic areas and will require an in-depth understanding of patient-centred outcomes research within the context of pharmaceutical development.

As a DPS implementation Scientist you will work closely with Patient Centric Science Directors, Study Teams/ Physicians, GCS DPS Service and GCS Solution Implementation Leads to implement eCOA into clinical trials to ensure high quality evidence supporting products regulatory approval, reimbursement and commercialization.

DPS Implementation Scientists will report directly to GCS DPS Services Director, and be part of DPS Service.

Key Accountabilities

• Tasked with implementing the PRO/COA strategy into DPS technology development and the eCOA solution.

• Accountable for the scientific aspect of the eCOA implementation, ensuring alignment with intended use and adherence to best practices and guidance.

• Holds overall accountability in PRO implementation and provides support for other COA (e.g., ClinRO) implementation when relevant.

• Collaborate with internal and external stakeholders (e.g., DPS Suppliers) to focus on implementing eCOA, in line with the CSP (Clinical Study Protocol) and PRO/COA strategy.

• Liaise with translation and linguistic validation suppliers, as well as license holders, to ensure eCOA is applied according to licensing guidelines.

• Facilitate the PRO/COA strategy development and CSP text regarding eCOA implementation.

• Assist in the development of PRO/COA training materials for patients, investigators, and monitors.

• Oversee the monitoring of eCOA compliance and manage issues related to eCOA during the trial.

• Ensure that appropriate standards are applied and contribute to the development of new standards.

• Collaborate in interactions with Regulatory authorities and engage with key external contacts in relation to eCOA implementation.

• Focused on AZ internal delivered studies, but with the possibility to support prioritized externally delivered studies

Essentialexperience/skills

• University Degree in Life Sciences, Clinical Research, Technology Science or equivalent

• Meaningful experience with clinical research from industry or CRO work experience, with demonstratable knowledge of pharmaceutical drug development process and/or software development process

• Experience with eCOA development, usage, implementation in clinical studies

• Able to implement projects including interactions with internal and external stakeholders

• Strong written and verbal communication and presentation skills

• Ability to define clear scope of projects and provide support

• Integrity and high ethical standards

• Excellent knowledge of spoken and written English

• Proactively identifies risks and issues and possible solutions