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

Staburo GmbH; München; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Benefits dieser Stelle

Hybrid work schedule

Remote work nationwide in Germany

Flexible working hours

Modern office with subsidised canteen

Zusammenfassung

Staburo GmbH is seeking a detail-oriented data science/life-sciences professional to manage redaction and anonymisation tasks for clinical trial documents. You will prepare RPDPs for EMA and Health Canada, disclose trial information to regulatory bodies, and maintain records while coordinating with international teams.

The role emphasizes data privacy, regulatory compliance, and collaboration within a CRO/biotech setting, with flexible hybrid work and potential full remote options within Germany.

Qualifikationen

• University degree in data science or lifescience 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

Aufgaben

• 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.

Kenntnisse

Fast comprehension

Analytical thinking

Teamwork

Initiative

Willingness to learn

Excellent time management

Good English skills

Ausbildung

University degree in data science or lifescience related discipline

Tools

R

SAS

Jobbeschreibung

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 lifescience 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].