Clinical Data Specialist
Shape the Future of Cancer Treatment at Luminate MedicalĀ
At Luminate, our mission is to make cancer care more human. Ā
Our first two products,Ā Lily and Lilac, are revolutionary wearable devices designed to address hair lossĀ
and peripheral neuropathy respectively - two of the most common and difficult side effects of cancerĀ
treatment. We have an exciting pipeline focused on building products that help cancer patients to live, notĀ
just survive. Lotus, our latest solution is a next-generation system designed to make at-home cancer careĀ
more accessible and efficient for both patients and clinics.Ā
Weāre looking for a Clinical Data Specialist to own and drive clinical data activities across our clinicalĀ
trials, from EDC build through to data cleaning and database readiness. This is an exciting opportunityĀ
to be part of a multi-award-winning team and play a decisive part in the development and productionĀ
of life changing devices. Above all, you will need to enjoy working in a fast-paced environment, beĀ
passionate about working with people, and thrive in taking responsibility for delivering projects on
time to make a real-world patient impact. Ā
Working at Luminate MedicalĀ
⢠This is a key early hire at a rapidly growing company. You will have an opportunity to shape theĀ
development of multiple high-impact patient-facing products and gain first-hand insights into theĀ
growth of a start-up.Ā
⢠We offer a highly competitive salary comparable with multinational medical device companies, aĀ
flexible benefits package (including health insurance and pension), alongside a company laptop,Ā
headphones and camera.Ā
⢠We believe in quality of life in our products and for our people, and offer flexible working hours,Ā
and a generous vacation policy.Ā
What You Will Do:Ā
⢠Manage clinical data activities across one or more clinical trialsĀ
⢠Generate and manage data queries with the EDC and work directly with clinical sites to resolveĀ
queries in a timely mannerĀ
⢠Develop and pull study reports (e.g., data listings, query reports, data completeness metrics)Ā
⢠Ensure data integrity and quality through ongoing data reviews, cleaning, and reconciliationĀ
activitiesĀ
⢠Support database lock activities and ensure audit readinessĀ
⢠Build, configure, and maintain EDC systems (including CRF design, edit checks, and dataĀ
structure, medical coding)Ā
⢠Lead User Acceptance Testing (UAT), including test script development and executionĀ
⢠Contribute to development of data management plans, data review guidelines, and SOPsĀ
⢠Identify opportunities to improve data workflows and implement scalable processes in a startupĀ
environmentĀ
Personal Attributes ā The Ideal Candidate Is:Ā
⢠Creative: A creative problem solver who is enthusiastic about new ideas. Ā
⢠Open: A proactive team player who seeks to help develop your teammates. You are willing toĀ
adopt, engage with and shape company culture in a positive manner. You can give and receiveĀ
candid feedback in a constructive and positive manner. Ā
⢠Communicative: Proficient in written and verbal communication and collaboration skills. You areĀ
able to share ideas and support exploration of other ideas. Ā Ā
⢠Self-Driven: You have a sense of urgency in your work and thrive when taking responsibility forĀ
tasks. Ā
⢠Organised: You can prioritise your list of tasks with input from more senior colleagues andĀ
ensure actions are completed on time.Ā
Experience Requirements ā The Ideal Candidate Must Have:Ā
Qualification: Bachelorās degree in Life Sciences, Clinical Research, Data Science, or related fieldĀ
Experience: 3ā7+ years with a Bachelorās Degree, or 0-3+ years of experience with a Masterās DegreeĀ
Technical Skills: Ā
⢠Experience or coursework related to clinical trial data captureĀ
⢠Hands-on experience with EDC systems (e.g., Clincapture Captivate, Medidata Rave, etc.) Ā
⢠Experience building EDCs (CRFs, edit checks, database structure) Ā
⢠Experience performing UAT Ā
⢠Understanding of data cleaning, query management, and database lock processesĀ
Communication Skills: Ā
⢠Experience working directly with clinical research sites to resolve queries Ā
⢠Ability to clearly communicate data issues and drive resolution across stakeholdersĀ
Experience Advantages ā It Would Be Advantageous to Have:Ā
⢠Experience in medical device clinical trials (especially NSR or pivotal studies)Ā
⢠Experience in startup, small teams, and/or fast-paced environmentsĀ
⢠Experience supporting regulatory submissions (e.g., FDA)Ā
⢠Experience supporting data analysis and collaborating with biostatisticians Ā
⢠Experience working on blinded studies or complex trial designsĀ
⢠Exposure to oncology trials and working with oncology research sitesĀ
Donāt have all of these requirements?Ā
Some people are less likely to apply for a role unless they are 100% qualified. Your experience, skillsĀ
and passion will set you apart ā tell us what you have learned and achieved, whether personal or work
related! With the right mindset, many of the skills above can be learned on the job. If this role excitesĀ
you, donāt let the description hold you back!