Clinical Data Manager Epidemiology

• Allrounder with combined experience in clinical data management, biostatistics, and hands‑on clinical study operations

• Strong passion for data integrity and all data‑related processes, combined with a proactive and solution‑oriented consulting mindset

• Sponsor‑side experience includes vendor oversight, DMP and DVP review, and ensuring data integrity and GxP compliance

• Offers expertise in SAS‑based statistical programming, including CDISC SDTM and ADaM dataset development as well as TLF generation

Clinical Data Manager / Interim Data Science Lead

• Performed end-to-end data management for Phase II/III trials from recruitment to database lock

• Assured sponsor oversight of all data management CRO activities

• Ensured high data quality through data monitoring, guaranteeing site and data compliance with ICH-GCP, regulatory requirements, and trial procedures

• Developed and reviewed SAS macros and outputs for risk based quality monitoring of CDISC SDTM datasets

• Established and reviewed technical documents, including protocols, eCRF completion guidelines, vendor management plans, and data management plans

• Conducted UATs for all study related vendor system (EDC, ePRO, eCOA etc.)

• Consistently delivered effective solutions to complex challenges

Biostatistician

• Developed and executed statistical analysis plans

• Programmed and performed dry run study analyses with mock data

• Conducted various statistical analyses

• Generated study reports including all TFLs

• Performed sample size estimation for multiple studies

RWE

• Conducted multiple analyses for non-interventional studies with comparator arms for their portfolio at that time

• Identified various comparators and summarize results from former studies

• Identify and quantify the patient population, who could have a benefit, so basically the epidemiology of atopic dermatitis and therapy gaps

• Worked on noninterventional studies (Project / Masters’ thesis)

• Conducted literature research on previous endpoints and on endpoint recommendations from regulatory authorities

• Consisted of testing 3 different statistical methods to find cutoffs simultaneously for this 3-way classification problem by data simulation in SAS

Clinical Research Coordinator / Clinical Operations

• Management of all non-medical tasks for Phase III and non-interventional studies on-site

• Administration of all vendor systems and supplies

• Training of all site staff on trial related aspects

Therapeutic areas: Oncology, Neurology, Immunology, Hematology, Gastroenterology, Rheumatology, Dermatology, Medical Devices

• Independent Sponsor-side data integrity review

• Focus on data integrity, protocol adherence, and subject safety

• Independent trial data clarity to support Sponsor oversight

• eCRF and non-eCRF data integrity review

• Data cleaning

• eCRF design, setup, and management

• DMP, DVP, SAP creation and review

• Biostatistics

• Consulting clinical research practices

• eCRF and non-eCRF data integrity review

• Data cleaning and validation

• Programming of clean patient tracker

• DMP, DVP, SAP creation and review

• Sponsor oversight of all CRO data management activities from protocol draft to submission

• eCRF and non-eCRF data integrity review

• Data standardization and CDISC SDTM review

• Trial issue/risk assessment and mitigation

• Consulting on study designs and data collection

• Statistical Analyses of medical device studies (TFLs)

• Author statistical analysis plans

• Sample size calculations

2019 – 2021

CRO Clinical Research Associate

2019 – 2019

MedTech Clinical Research Associate

2018 – 2019

Pharmaceutical Company Clinical Research Associate

2017 – 2018

Digital Health Company Scientific Consultant

2017 – 2017

CRO Biostatistician

2011 – 2013

University of Applied Sciences Teaching Assistant Epidemiology, Surveillance, Reporting

2015 – 2016

Pharmaceutical Company Intern Biometrics & Epidemiology

2011 – 2011

University Medical Center Intern Clinical Epidemiology