Clinical Data Specialist
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Luminate Medical
Chicago, IL (In Person)
Full-Time
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Job Description
Shape the Future of Cancer Treatment at Luminate Medical At Luminate, our mission is to make cancer care more human. Our first two products, Lily and Lilac , are revolutionary wearable devices designed to address hair loss and peripheral neuropathy respectively - two of the most common and difficult side effects of cancer treatment. We have an exciting pipeline focused on building products that help cancer patients to live, not just survive. Lotus , our latest solution is a next-generation system designed to make at-home cancer care more accessible and efficient for both patients and clinics. We're looking for a Clinical Data Specialist to own and drive clinical data activities across our clinical trials, from EDC build through to data cleaning and database readiness. This is an exciting opportunity to be part of a multi-award-winning team and play a decisive part in the development and production of life changing devices. Above all, you will need to enjoy working in a fast-paced environment, be passionate about working with people, and thrive in taking responsibility for delivering projects on
time to make a real-world patient impact. Working at Luminate Medical
- This is a key early hire at a rapidly growing company. You will have an opportunity to shape the development of multiple high-impact patient-facing products and gain first-hand insights into the growth of a start-up.
- We offer a highly competitive salary comparable with multinational medical device companies, a flexible benefits package (including health insurance and pension), alongside a company laptop, headphones and camera.
- We believe in quality of life in our products and for our people, and offer flexible working hours, and a generous vacation policy.
What You Will Do:
- Manage clinical data activities across one or more clinical trials
- Generate and manage data queries with the EDC and work directly with clinical sites to resolve queries in a timely manner
- Develop and pull study reports (e.g., data listings, query reports, data completeness metrics)
- Ensure data integrity and quality through ongoing data reviews, cleaning, and reconciliation activities
- Support database lock activities and ensure audit readiness
- Build, configure, and maintain EDC systems (including CRF design, edit checks, and data structure, medical coding)
- Lead User Acceptance Testing (UAT), including test script development and execution
- Contribute to development of data management plans, data review guidelines, and SOPs
- Identify opportunities to improve data workflows and implement scalable processes in a startup environment Personal Attributes -
The Ideal Candidate Is:
Creative:
A creative problem solver who is enthusiastic about new ideas.Open:
A proactive team player who seeks to help develop your teammates. You are willing to adopt, engage with and shape company culture in a positive manner. You can give and receive candid feedback in a constructive and positive manner.Communicative:
Proficient in written and verbal communication and collaboration skills. You are able to share ideas and support exploration of other ideas.Self-Driven:
You have a sense of urgency in your work and thrive when taking responsibility for tasks.Organised:
You can prioritise your list of tasks with input from more senior colleagues and ensure actions are completed on time. Experience Requirements -The Ideal Candidate Must Have:
Qualification:
Bachelor's degree in Life Sciences, Clinical Research, Data Science, or related fieldExperience:
3-7+ years with a Bachelor's Degree, or 0-3+ years of experience with aMaster's Degree Technical Skills:
- Experience or coursework related to clinical trial data capture
- Hands-on experience with EDC systems (e.g., Clincapture Captivate, Medidata Rave, etc.)
- Experience building EDCs (CRFs, edit checks, database structure)
- Experience performing UAT
- Understanding of data cleaning, query management, and database lock processes
Communication Skills:
- Experience working directly with clinical research sites to resolve queries
- Ability to clearly communicate data issues and drive resolution across stakeholders Experience Advantages - It Would Be Advantageous to
Have:
- Experience in medical device clinical trials (especially NSR or pivotal studies)
- Experience in startup, small teams, and/or fast-paced environments
- Experience supporting regulatory submissions (e.g., FDA)
- Experience supporting data analysis and collaborating with biostatisticians
- Experience working on blinded studies or complex trial designs
- Exposure to oncology trials and working with oncology research sites Don't have all of these requirements?
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