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 45 experts supports our clients efficiently from study design to data analysis and finally the disclosing and posting of trial results.
To expand our team in Munich (remote possible), we are looking for a
Disclosure Manager / Clinical Trial Transparency Specialist (f/m/d)
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 & global regulatory agencies
- Review of study protocols, amendments, and reports for disclosure readiness
- Review of documents and content during the quality check processes
- 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
- Communicate and coordinate with international study teams, act as a central point of contact
- Bachelor’s, Master’s or PhD degree in a health or life science related discipline
- Experience in medical writing is a plus
- Knowledge of drug development and clinical science
- Knowledge of the clinical trials disclosure regulatory environment and experience with Clinicaltrials.gov and/or EudraCT is a plus
- Work experience in CRO or pharma/biotech is a plus
- Fast comprehension, analytical thinking, teamwork and a high degree of initiative, willingness to learn
- Excellent organizational and time management skills, highly detail-oriented
What we offer you:
As a quality provider of statistical consulting, we truly believe that delivery of high-quality services is the foundation of our stable and growing team. Therefore, we give you time for your core job competencies by minimizing organizational burden. Our continued trainings keep you up to date on all regulatory requirements. We value communication, flat hierarchies, open corporate culture, and a harmonious work environment. We offer comprehensive individual development opportunities and flexible working hours.
Check our website: www.staburo.de and become part of our constantly growing team! Please send your complete application documents by e-mail to: email@example.com. We look forward to meeting you soon!