Permanent employee

Staburo GmbH; München; Hybrid; EUR 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

Partial/Full remote options

Zusammenfassung

Staburo GmbH is seeking a data privacy and regulatory professional to assess data sharing requests, review consent forms, redact CCI/PPD in documents, and prepare RPDP packages for EMA and Health Canada. You will coordinate with international study teams, maintain study records, and manage timelines to ensure compliance with global regulatory requirements.

You will work in a fast-paced CRO/pharma environment with opportunities for growth and professional development, with the possibility of

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 RPDP packages for EMA and Health Canada submission 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 regulatory agencies
• Maintenance of study records including status tracking and administrative aspects
• Managing timelines for timely submission to ensure compliance with international laws and guidelines
• Communicate and coordinate with international study teams, act as a central point of contact

Kenntnisse

Data analysis

Regulatory coordination

Attention to detail

English communication

Ausbildung

University degree in data science or life sciences

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].