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05.12.2021

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Staburo GmbH
Aschauer Straße 26a
81549 München

Einsatzort:

München

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Roland Stieger
08955271520

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To expand our team in Munich (remote possible), we are looking for a

Disclosure Manager / Clinical Trial Transparency Specialist (f/m/d)

Disclosure Manager / Clinical Trial Transparency Specialist (f/m/d)

05.09.2021
Staburo - München
Biomedizinische Technik, Gesundheitsmanagement, Gesundheitsökonomie, Humanmedizin, Mathematik, Medizin, Statistik

Aufgaben

• 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 inter-national laws, regulations, and guidelines
• Communicate and coordinate with international study teams

Qualifikation

• 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

Benefits

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.

Weitere Angaben

Sprachkenntnisse: Englisch - Deutsch
Beginn: 01.10.2021
Dauer: unbefristet
Vergütung:
Anzahl der Plätze: 1

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21-50 Mitarbeiter

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