Data Transparency Specialist

Vor 6 Tagen


München, Deutschland Staburo GmbH Vollzeit

**Your responsibilities will include**:

- Redaction of clinical trial documents
- Anonymisation of individual patient data
- Assessing data sharing requests, reviewing informed consent forms for data sharing feasibility
- Disclosure activities for drug and device clinical trial information:

- Authoring of protocol registrations and results postings 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 life science related discipline
- Knowledge of drug development and clinical science
- Experience in redaction of CCI and PPD in clinical documents
- Knowledge of EMA policy 0070 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, 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.


  • Data Specialist

    Vor 4 Tagen


    München, Deutschland Data Specialist (mwd) Vollzeit

    Die **Max Planck Digital Library** (MPDL) in München ist eine zentrale Serviceeinrichtung der Max-Planck-Gesellschaft zur Förderung der Wissenschaften e. V. (MPG). Wir unterstützen Wissenschaftler*innen der gegenwärtig 84 Max-Planck-Institute und Forschungsstellen im In - und Ausland mit einem breiten Service-Portfolio, das ihnen einen einfachen Zugang...


  • Berlin, Bielefeld, Dresden, Dortmund, Heidelberg, Hamburg, Köln, München, Pforzheim, Stuttgart, Deutschland NTT DATA Business Solutions AG Vollzeit

    Als Teil des Teams von NTT DATA Business Solutions AG bist du verantwortlich für die Entwicklung und Umsetzung von Datenmigrationen für SAP-Anwendungen. Du arbeitest eng mit unserem Data Migration Lead und anderen Entwicklern zusammen, um komplexe Datenmigrationen zu entwickeln und zu implementieren.Deine Aufgaben umfassen:Die Entwicklung von...


  • München, Deutschland GENERALI DEUTSCHLAND AG Vollzeit

    **BEI DER GENERALI DEUTSCHLAND AG NEUE PERSPEKTIVEN ENTDECKEN ALS** Leiter (m/w/d) der Einheit People Transparency & Planning in Köln, München Überblick Die Generali ist eine der führenden Erstversicherungsgruppen im deutschen Markt. Als Teil der internationalen Generali Group ist die Generali in Deutschland mit den Marken Generali, CosmosDirekt und...


  • München, Deutschland Klüber Lubrication Vollzeit

    Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments. Klüber Lubrication, a...


  • 80331 München, Deutschland ZeroEx Vollzeit

    **Location**: Munich, Germany (Hybrid) **About Us**: ZeroEx is leading the charge in climate action by leveraging advanced technology and practical CO2 removal solutions to combat global warming. Our mission is to make an immediate and meaningful impact through proactive CO2 removal from the atmosphere. We value curiosity and empathy and are looking for...


  • München, Deutschland Microsoft Vollzeit

    As a Sales Activation Specialist in our Sales Activation and Transformation (SAT) team, you will use your consulting and sales skills to position, propose, and sell implementation services for Microsoft’s Data & AI to our most strategic accounts. Your deep understanding of how Data & AI solutions transform and modernise businesses will be fundamental as...


  • München, Deutschland Zühlke Vollzeit

    If you share our values and want to do the best work, for the right reasons, we can offer you the chance to do it on a global scale and play a real role in shaping our exciting journey. How you’ll make impact - Architecture & Implementation: You design sophisticated architectures for data and AI projects, implementing them together with your team while...


  • München, Deutschland Birkenstock Group B.V. & Co. KG Vollzeit

    BIRKENSTOCK is a global brand which embraces all consumers regardless of geography, gender, age and income. The company is deeply footed on a family tradition of shoemaking that can be traced back to 1774. With around 6200 employees worldwide, BIRKENSTOCK is the largest employer in the German footwear industry. To ensure our quality standards, we produce...


  • München, Deutschland Amazon TA Vollzeit

    At Amazon, we're working to be the most Customer-centric company on earth. The program gives entrepreneurs an opportunity to develop a successful package delivery business with low startup costs and access to Amazon's technology and logistics experience. DSP Acquisition Specialist is an integral partner in managing recruiting and onboarding activities from...


  • Garching bei München, Bayern, Deutschland Oerlikon Vollzeit

    Data Management Engineer RoleAt Oerlikon, we are seeking a highly skilled Data Management Engineer to join our Innovation Hub team in Garching. As a key member of our team, you will play a vital role in designing, implementing, and optimizing our data management infrastructure, encompassing databases, data warehouses, and data lakes.Your...


  • München, Deutschland NTT DATA Deutschland SE Vollzeit

    NTT DATA gehört zu den weltweit führenden Dienstleistern für Business- und IT-Lösungen. Mit Weitsicht und Innovationskraft schaffen wir außergewöhnliche Lösungen auf dem Weg in eine nachhaltige und vernetzte Zukunft. #Flexible Arbeitszeiten mit Gleitzeitregelung und Reisezeit ist Arbeitszeit 30 Tage Urlaub, zusätzlich sind der 24.Sabbatical bis zu...


  • München, Deutschland Amazon TA Vollzeit

    At Amazon, we're working to be the most Customer-centric company on earth. The program gives entrepreneurs an opportunity to develop a successful package delivery business with low startup costs and access to Amazon's technology and logistics experience. DSP Acquisition Specialist is an integral partner in managing recruiting and onboarding activities from...


  • München, Deutschland NTT DATA Deutschland SE Vollzeit

    NTT DATA gehört zu den weltweit führenden Dienstleistern für Business- und IT-Lösungen. Mit Weitsicht und Innovationskraft schaffen wir außergewöhnliche Lösungen auf dem Weg in eine nachhaltige und vernetzte Zukunft. Von Connect bis zu Create kombinieren wir globale Präsenz mit lokaler Marktkenntnis und begleiten unsere Kunden mit einem umfangreichen...

  • Senior Specialist

    vor 3 Monaten


    München, Deutschland SIXT Germany Vollzeit

    Do you enjoy working on interesting, varied topics while always ensuring that personal data is protected? Then we have the perfect job for you! **DO WHAT YOU LOVE**: - You advise management and specialist departments on data protection issues and help them implement projects in compliance with data protection regulations - You are responsible for ensuring...

  • Senior Specialist

    vor 3 Monaten


    München, Deutschland SIXT Germany Vollzeit

    Do you enjoy working on interesting, varied topics while always ensuring that personal data is protected? Then we have the perfect job for you! **DO WHAT YOU LOVE**: - You advise management and specialist departments on data protection issues and help them implement projects in compliance with data protection regulations - You are responsible for ensuring...


  • München, Deutschland Amazon Web Services Development Center Germany GmbH Vollzeit

    5+ years management of technical, customer facing resources - 5+ years of hands-on experience with AI/ML or related technology domain - 5+ years of hands-on experience with building ML/data pipelines, data engineering, or similar technologies The Worldwide Specialist Organization (WWSO) is part of AWS Sales, Marketing, and Global Services (SMGS), which is...


  • München, Deutschland Celonis SE Vollzeit

    We're Celonis, the global leader in Process Mining technology and one of the world's fastest-growing SaaS firms. We believe there is a massive opportunity to unlock productivity by placing data and intelligence at the core of business processes - and for that, we need you to join us. **The Team**: As a member of the Engineering organization, the Product...

  • Data Specialist

    vor 1 Woche


    80687 München, Deutschland Max-Planck-Gesellschaft Vollzeit

    **MÜNCHEN*** Ausschreibungsnummer: 480 Stellenangebot vom 6. Dezember 2024 Die **Max Planck Digital Library (MPDL)** in München ist eine zentrale Serviceeinrichtung der Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. (MPG). Wir unterstützen Wissenschaftlerinnen und Wissenschaftler der gegenwärtig 86 Max-Planck-Institute und...

  • Data Trainee

    vor 3 Monaten


    München, Deutschland PAYBACK GmbH Vollzeit

    **DATA TRAINEE (M/F/D)**: **General information**: Job Title Data Trainee (M/F/d) Ref # 628 Location Munich Company PAYBACK GmbH Job Area Analytics Job Type Trainee **Description & Requirements**: PAYBACK is a top player in data-driven marketing worldwide. With the ability to develop digital business models and implement technical trends, we are one...


  • München, Deutschland Celonis SE Vollzeit

    We're Celonis, the global leader in Process Mining technology and one of the world's fastest-growing SaaS firms. We believe there is a massive opportunity to unlock productivity by placing data and intelligence at the core of business processes - and for that, we need you to join us. **(Senior) Training Specialist - EMEA MUC** **The Team**: You will be...