Transparency Specialist - Munich, Deutschland - Staburo GmbH

Staburo GmbH

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 and redaction of study documents
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 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 detailoriented
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.