Clinical Data Associate - Working Student

What we are doing
Our mission is to prevent vision loss and ultimately blindness by developing AI software that assists eye doctors in therapy planning for their patients. We use computer vision deep learning models (AI) trained on thousands of cases and millions of images to predict disease progression individualize therapy and improve outcomes. The decision support algorithm targets widespread eye diseases like Agerelated Macular Degeneration (AMD 7.5 million affected in Germany alone).

Tasks

Your responsibilities as a Clinical Data Associate
As a Clinical Data Associate your primary responsibility will be to ensure the validity and integrity of clinical trial data. You will design data collection instruments manage databases and track the flow of data from investigative sites. Your role includes drafting and managing data management plans (DMPs) developing electronic Case Report Forms (eCRFs) and performing data monitoring. You will also assist in the review and resolution of data discrepancies and ensure all data is formatted according to clinical information systems (CIS) standards.

Specific tasks include:

• Drafting finalizing and managing data management plans (DMPs).
• Developing eCRFs and managing database core builds.
• Conducting electronic data capture (EDC) specification and user acceptance testing.
• Monitoring data entry and ensuring timely data discrepancies resolution.
• Participating in the evaluation and implementation of clinical trial management systems (CTMS) like SimpleTrials and greenlight guru.
• Documenting all work according to established standard operating procedures (SOPs) and conducting database audits to ensure compliance with Good Clinical Practice (GCP ISO 14155).

Your success in this role will be evident when the clinical data you manage is accurate properly formatted and available in a timely manner ensuring smooth and reliable progress of clinical trials. Your work will directly contribute to the quality and reliability of our AI solutions helping eye doctors deliver better patient outcomes.

Requirements

Your musthaves

• BA/BS in a relevant field and 13 years of clinical data management experience in medical devices.
• Experience with database management systems (e.g. SMARTtrial greenlight guru Clinical RedCap).
• Familiarity with Clinical Trial Management Systems (CTMS) like SimpleTrials.
• Proficiency in computer software applications relevant to data management.
• Strong organizational skills and attention to detail to manage multiple tasks and meet deadlines.
• Excellent communication skills and the ability to work crossfunctionally with teams like clinical operations data analysis and IT.

Your nicetohaves

• Experience in ophthalmology or clinical research in AI or digital health.
• Knowledge of regulatory standards (e.g. GCP ISO 14155) and data coding practices.
• Advanced degree in a related field (e.g. Clinical Data Management Biomedical Sciences).
• Experience with electronic data capture (EDC) systems and user acceptance testing.
• Knowledge of additional languages that could be beneficial in our global outreach (e.g. French Dutch).

Benefits

What we offer

• Direct impact on improving the quality of life for patients & doctors.
• Immediate responsibility in managing and maintaining crucial clinical data.
• Flexible working hours remote work and a central office at Munich main station.
• Openminded startup culture & a diverse team (10 nationalities 30year age span 45% female) of experts (>10 startups >100 medical devices >100k retinal therapies).