Senior eClinical Business Lead, IRT/DHT design - UK
Parexel, Uxbridge, England, United Kingdom
Picture Yourself At Parexel
The role provides consultation on the Randomization and Trial Supply Management (RTSM) and Digital Health Technology (DHT e.g., eCOA, eConsent) system design. The individual analyses study protocols and collaborates with stakeholders to create user requirements to meet the study needs. They identify and mitigate risks related to RTSM and DHT design and ensure that overall deliverables align with internal and external client expectations. The role also oversees User Acceptance Testing (UAT) of RTSM and DHT systems, managing projects, budgets, and quality standards.
What You’ll Do At Parexel
* Provide consultation to Project Leaders and other study team members on RTSM and DHT study design.
* Analyse protocols and collaborate with stakeholders to create and review User Requirements.
* Identify and mitigate risks related to RTSM and DHT study design.
* Translate complex requirement descriptions into clear language for the study team.
* Understand integrations and identify potential integration user requirement issues.
* Work closely with UAT Leads.
* Stay current on RTSM and DHT technology and clinical trial process developments.
* Manage quality control and timely delivery of project deliverables.
* Interact with external clients regarding RTSM and DHT design and protocol elements.
* Demonstrate a proactive approach to providing solutions in a timely manner.
* Maintain knowledge of applicable ICH Guidelines and Good Clinical Practices.
* Complete routine administrative tasks in a timely manner.
Ideal Candidate Will Possess
* At least 12 months experience in IRT/RTSM and/or Digital Health Technology system delivery.
* Knowledge of Clinical Research Services and vendor software/tools.
* Experience in clinical trial systems (CTMS, EDMS, EDC, IRT, reporting tools) and their configuration.
* Ability to work autonomously.
* Experience coordinating global virtual teams for trial technology set‑up.
* Strong project management skills.
* Excellent verbal and written communication skills.
* Fluent English.
* Strong customer focus.
* Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH‑GCP and related regulations.
* Understanding of data standards such as CDISC SDTM.
* In-depth understanding of clinical trial processes.
* Demonstrated learning agility in evolving technical environments.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job Function
Management and Manufacturing
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