IT Clinical Project Manager - Manager Digital Innovations
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- 22587 Hamburg
- Weltweit
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- 15.11.2024
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
7/2024 – 9/2024
TätigkeitsbeschreibungEntwicklung einer Digitalstrategie für DiGA Zulassung sowie Real-World-Evidence Gewinnung
Eingesetzte QualifikationenConsultant, IT-Berater, Projektleiter Gesundheitswesen
1/2023 – 12/2024
TätigkeitsbeschreibungManage start-up phase for pediatric study with medical device class III in neurology; develop new indication for medical device class III, manage and set-up pilot-study
Eingesetzte QualifikationenClinical Study Manager, Projektleiter Gesundheitswesen
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), Gute Klinische Praxis, Klinische Forschung, 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 Forschung, 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 QualifikationenGute Klinische Praxis, 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 QualifikationenDrug Discovery
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
DiGA strategy
Clinical IT systems (Apps, platforms) development & implementation
Medical devices class I, III studies
Oncology, Dermatology, Rare Disease, Immunology, Urology, Allergy, and other
Various Clinical Trial Management and eCRF capture systems
Project management skills
Team building capacity
Budget forecasts and -handling
Project reporting
Sponsor & KOL 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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