Data Transparency Specialist – Data Sharing, Anonymisation and Clinical Trial Disclosure (f/m/d -

Your responsibilities will include

• Assessing data sharing requests, reviewing informed consent forms for data sharing feasibility
• Redaction of clinical trial documents and anonymisation of individual patient data
• Preparing Redaction Proposal Document Packages (RPDP) for submission to EMA and Health Canada in compliance with EMA Policy 0070 and Health Canada PRCI
• Disclosure of clinical trial information for drugs and medical devices: Registering protocols and preparing results for submission to local and global regulatory agencies
• Maintenance of study records including status tracking and administrative aspects
• Managing timelines for timely submission to ensure compliance with international laws, regulations, and guidelines
• Communicate and coordinate with international study teams, act as a central point of contact

Your profile

• University degree in data science or life science related discipline
• Knowledge of drug development and clinical science
• Experience in redaction of CCI and PPD in clinical documents is a plus
• Knowledge of EMA policy 0070 and Health Canada PRCI is a plus
• Experience in data anonymization and programming (e.g., R/SAS) is a plus
• Knowledge of the clinical trials disclosure regulatory environment and experience with Clinicaltrials.gov and EudraCT/CTIS is a plus
• Experience in medical writing is a plus
• Fast comprehension, analytical thinking, teamwork and a high degree of initiative, willingness to learn
• Work experience in a CRO or pharma/biotech is a plus
• Excellent organizational and time management skills, highly detail-oriented
• Good English skills

What we offer you

We value communication, flat hierarchies, open corporate culture, and a harmonious work environment. We offer comprehensive individual development opportunities, continuous trainings, and flexible working hours. A modern and bright office with a subsidised canteen, as well as the opportunity to work 2 days per week from home are part of our everyday working life. Full remote work from anywhere in Germany for those who do not live in Munich can be discussed. You will join an interdisciplinary team allowing you to discuss with and learn from peers with many different backgrounds.

Question?

If you have any questions, please feel free to contact us by e-mail application@staburo.de.

About us

Staburo GmbH is a data science company, specialized in statistical consulting, programming and bioinformatics for healthcare projects. Our core competencies include Clinical Statistics, Translational Medicine & Biomarkers, Phase I & Pharmacokinetics/-Dynamics, Data Transparency & Disclosure Services, Health Technology Assessment and Bioinformatics. Our customers are international pharmaceutical companies (7 of the top 20), CROs, biotech companies and medical device manufacturers. Our steadily growing team of 110 experts supports our clients efficiently from study design to data analysis and finally the disclosing and posting of trial results.