Transparency Specialist

Vor 3 Tagen

Munich, Deutschland Staburo GmbH Vollzeit

**Your responsibilities will include**:

- All posting activities for drug, device, and biologic clinical trials
- Authoring of protocol registrations and results postings for submission to local and global regulatory agencies
- Maintenance of international clinical trial registry and results records on public databases including status tracking and administrative aspects
- Managing timelines for timely submission of all registrations and postings to ensure compliance with international laws, regulations, and guidelines
- Review of study protocols, amendments, informed consent forms, and reports for disclosure readiness
- Data and document sharing: data anonymization, redaction of study documents, and assessing informed consent forms for data sharing
- Communicate and coordinate with international study teams, act as a central point of contact

**Your profile**:

- University degree in health or life science related discipline
- Knowledge of drug development and clinical science
- Knowledge of the clinical trials disclosure regulatory environment and experience with Clinicaltrials.gov and EudraCT/CTIS is a plus
- Experience in medical writing and document redaction is a plus
- Experience in data anonymization and programming (e.g., R/SAS) 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, German is an advantage

**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?**:
**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, CROs, biotech companies and medical device manufacturers. Our steadily growing team supports our clients efficiently from study design to data analysis and finally the disclosing and posting of trial results.

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