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For Companies At a Glance
- Tasks: Manage clinical systems, user access, and support system validation and updates.
- Company: Join Autolus Therapeutics, a diverse employer committed to inclusivity and the LGBTQ+ community.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Be part of impactful clinical studies while working with innovative technologies and supportive teams.
- Qualifications: Looking for organised individuals with strong attention to detail and teamwork skills.
- Other info: This role offers a chance to contribute to meaningful healthcare advancements.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Role Summary
We are seeking a highly skilled and organized Clinical Systems Specialist to support the management and functionality of clinical systems and processes. The ideal candidate will be responsible for ensuring the smooth management of user access, performing system validation, and collaborating with cross-functional teams for system updates, releases, and configuration changes. This role will support the review of release notes, contribute to UAT processes and manage system configurations and updates related to clinical studies.
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
#LI-DNI
Clinical Systems Specialist employer: Autolus Therapeutics
Contact Detail:
Autolus Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Systems Specialist
✨Tip Number 1
Familiarise yourself with clinical systems and their functionalities. Understanding the specific systems used in clinical trials will give you an edge during interviews, as you'll be able to discuss how your skills align with the role's requirements.
✨Tip Number 2
Network with professionals in the clinical research field. Attend industry events or join online forums where you can connect with current Clinical Systems Specialists. This can provide insights into the role and potentially lead to referrals.
✨Tip Number 3
Brush up on your user management and access control knowledge. Being able to demonstrate your understanding of user roles, permissions, and compliance standards will show that you're prepared for the responsibilities of the position.
✨Tip Number 4
Prepare for potential technical questions related to system validation and User Acceptance Testing (UAT). Having examples ready from your past experiences will help you articulate your expertise and problem-solving abilities effectively.
We think you need these skills to ace Clinical Systems Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Clinical Systems Specialist position. Understand the key responsibilities and required skills, as this will help you tailor your application.
Tailor Your CV: Customise your CV to highlight relevant experience and skills that align with the responsibilities of the role. Emphasise your experience in user management, system validation, and collaboration with cross-functional teams.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention specific experiences that demonstrate your ability to manage clinical systems and your understanding of compliance and regulatory guidelines.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for the Clinical Systems Specialist role.
How to prepare for a job interview at Autolus Therapeutics
✨Understand the Role
Make sure you thoroughly understand the responsibilities of a Clinical Systems Specialist. Familiarise yourself with user management, system validation, and UAT processes. This will help you answer questions confidently and demonstrate your knowledge during the interview.
✨Showcase Your Technical Skills
Be prepared to discuss your experience with clinical systems and any relevant software tools. Highlight specific examples where you've managed user access or performed system validations. This will show that you have the technical expertise needed for the role.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific situations, such as managing user access or collaborating with cross-functional teams. Think of examples from your past experiences that illustrate your problem-solving skills and ability to work in a team.
✨Ask Insightful Questions
At the end of the interview, be ready to ask questions about the company's culture, the team you'll be working with, and the systems they use. This shows your genuine interest in the role and helps you determine if it's the right fit for you.
