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Clinical Systems Specialist

Clinical Systems Specialist

Autolus LimitedLondon, England, United Kingdom
30+ days ago
Job type
  • Full-time
Job description

Clinical Systems Specialist page is loaded## Clinical Systems Specialistlocations : UK - London, White Citytime type : Full timeposted on : Posted 13 Days Agotime left to apply : End Date : October 3, 2025 (23 days left to apply)job requisition id : JR100037

  • Work with us
  • Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.
  • Job Description :
  • Key Responsibilities
  • User Management & Access Control :
  • Create and manage User Management Forms for system users.
  • Oversee the granting and revocation of user access rights, ensuring compliance with organizational protocols and security standards.
  • Run monthly user rights reports and handle any accounts new or to be disabled.
  • Ensure that user roles and permissions are correctly assigned across systems and modules.
  • System Validation :
  • Support the review of Release Notes for system changes, including assessing impact and ensuring proper implementation across relevant systems and modules.
  • Support the User Acceptance Testing (UAT) and document creation collaborating with the IT and CSV team.
  • Support the end user training.
  • Support on the implementation of any new modules, systems and configurations on current systems.
  • Perform system validation tasks to ensure that clinical systems operate according to specified requirements and regulatory guidelines.
  • Collaborate with the IT and CSV teams to support User Acceptance Testing (UAT), ensuring that changes meet functional and technical requirements.
  • Study and Site Management :
  • Add new clinical study, country, sites, Principal Investigators (PIs), Sub-Investigators (Sub Is), participants, vendors into the clinical system as necessary.
  • Update and maintain accurate CSV entries to reflect the most current information.
  • Create, review, and maintain templates and wizard configurations in the clinical system to ensure accuracy and compliance with study protocols.
  • Provide ongoing support for system changes and upgrades, working with teams to ensure system functionality aligns with operational needs.
  • Provide support to study teams for document uploads and QC, as required
  • Demonstrated skills and competencies
  • E – Essential
  • P – Preferred
  • Experience :
  • Knowledge of system validation and UAT processes (E)Experience with Clinical Trial Management Systems (CTMS), eTMF, Electronic Data Capture (EDC), RAVE, Medidata (P)Experience in a clinical or system management role, preferably in the clinical trials or healthcare industry (P)
  • Qualifications
  • Bachelors or Masters Degree (E) in Science (P)
  • Skills / Specialist knowledge
  • Strong attention to detail.Ability to collaborate effectively across teamsExcellent communication skills, both written and verbal.Proficiency in Microsoft Office and other relevant software.
  • Autolus Core Competencies
  • Focus on Results :
  • Works to meet business goals set by management and leaders
  • Builds Trust and Relationships :
  • Ensures trust with internal and external partners by delivering on commitments
  • Resilience :
  • Has the capacity to recover quickly from difficulties; toughness
  • Communicates and Collaborates :
  • Builds partnerships and works collaboratively with others to meet objectivesAutolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard.Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.### Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.

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Clinical Specialist • London, England, United Kingdom

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