IT Clinical Project Manager - Manager Digital Innovations
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- 22587 Hamburg
- Weltweit
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- 13.12.2022
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
12/2020 – 12/2022
Tätigkeitsbeschreibung
Management & oversight for DTx in clinical studies
Provide training of pharma-, CRO- and study site teams for DTx use
Develop a repository of study materials (patients, sites, sponsor)
Develop a system & database for sponsor reporting
CRM (Customer Relationship Management), Enterprise project management (EPM), Good clinical practice (GCP), Klinische Studie, User Experience (UX)
11/2020 – 11/2022
TätigkeitsbeschreibungSet-up of studies with COVID-19 positive patients under special quarantine-, hygiene- and safety standards for study personnel, implementation of a digital diary for ePRO (symptom diary)
Eingesetzte QualifikationenKlinische Studie, Projektleitung / Teamleitung
12/2018 – 11/2020
TätigkeitsbeschreibungDevelop business cases for apps in clinical studies, act as POC for clinical teams; assist for device enablement; provide 2nd level support; capacity planning; translate clinical team requirements into user stories & development visions; communication with senior stakeholders to communicate digital vision & strategy within the company; guide & oversee IT governance review (IT security, data privacy, data transfers...); new generation wearables implementation in studies; develop data transfer agreements with partners; develop concepts for secure data storage & transfer from digital devices (apps, wearables);
Eingesetzte QualifikationenGood clinical practice (GCP), IT-Governance, Projektmanagement (IT)
11/2017 – 7/2018
TätigkeitsbeschreibungScientific advice support, writing scientific text for marketing authorization dossiers, writing scientific summaries for external and internal stakeholders
Eingesetzte QualifikationenPharmaforschung
2/2016 – 1/2017
TätigkeitsbeschreibungPhase III study, indication grass pollen allergy, project management and monitoring
Eingesetzte QualifikationenManagement (allg.)
1/2012 – 11/2013
TätigkeitsbeschreibungManagement of an international Phase IIb study, indication Primary Immune Disease (rare disease)
Eingesetzte QualifikationenManagement (allg.)
12/2011 – 11/2013
TätigkeitsbeschreibungLeitung von internationalen klinischen Studien Phase II und III mit Verantwortlichkeit für Budgets und Timelines
Eingesetzte QualifikationenProjektleitung / Teamleitung, Medizin
Ausbildung
Technische Universität Berlin
Institut für Anthropologie, Univ. Hamburg
Universität Hamburg
Über mich
• Demonstrated extreme success in complex project management in both small enterprises as well as bigger matrix organizations;
- managed very well initiatives aimed at implementing customer-oriented and measurable data and process improvements
• Build relations and partnerships across therapeutic areas within & outside the company to deliver data from high-quality digital products, solutions, and strategies
• Convert patient- and health care provider needs into visible digital solutions and digital platforms to improve their experience and data delivery within clinical research
• applies strong strategic thinking for implementing digital tools within pharma-, CRO- and patient environments
• Support clinical teams to integrate innovative digital solutions
• Facilitate integration of data from digital innovative devices (sensor wearables, medical apps and other) into the pharma- or CRO data rooms
• Develop data collection methods for remote instruments to achieve insights in before non-visible data points
• Support innovative Start-ups to integrate their high-tech solutions into clinical research and real-world trials
• Customer-oriented, pragmatic problem-solving and tech-savvy mindset with a strong outcome focus and an attention to detail
• Understanding innovative processes, agile management and data technologies
• Excellent project management skills including budget, resources and timeline responsibilities
• high conflict resolution and negotiation skills
• Excellent organizational skills; used to keep deadlines and make decisions
Weitere Kenntnisse
Various Clinical Trial Management and eCRF capture systems
Project management skills
Team building capacity
Budget forecasts and -handling
Project reporting
Sponsor relations
Vendor management
Science communication and -marketing
Data visuation via Qlik, PowerBI etc
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Französisch (Fließend)
- Spanisch (Grundkenntnisse)
- Europäische Union
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