19.08.2026 aktualisiert
Premiumkunde
100 % verfügbarConsultant Clinical Trials, Medical Writer, Process Manager, Translator
Neuhofen, Deutschland
Nur Remote
Graduate Translator/Interpreter German English GermanÜber mich
My recent experience has focused on supporting global pharmaceutical and oncology studies for leading global research organisations. I served as CRC at Klinikum Ludwigshafen in 2025 and I oversaw European study sites including Veeva Vault database research and filing of regulatory documents.
Skills
Klinische BewertungRepository für Klinische DatenKlinische ForschungClinical Trial Management System
Clinical Data, CTMS, clinical trial management systems, Data Monitoring, Data Management, Database Systems, database, Electronic data capture, GoToMeeting, MS Office, SharePoint, Oracle, SAP R/3, Spreadsheets, CER, CEP, VEEVA
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2010
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischgut
Projekthistorie
My recent experience has focused on supporting global pharmaceutical and oncology studies for leading global research organisations. Most recently I served as Clinical Research Coordinator at the derma-oncology ward of Klinikum Ludwigshafen, leading a study team in coordinating a Phase III clinical trial for adjuvant treatment of patients with completely resected high-risk melanoma. Prior to that, I served as Clinical Research Coordinator for Viridian Therapeutics, a clinical-stage biotech company specialising in rare diseases. My recent achievements include:
- Delivering major contributions to Berlin 2025 and Amsterdam 2023 International Investigator Meetings, preparing highly structured, precise and reliable data under challenging deadlines.
- Performing up to 3 site visits per week over 12 months for Klinikum Ludwigshafen, including training, for major sponsor Regeneron.
- Stepping in to lead site start-up for a 2nd clinical trial in neoadjuvant / perioperative setting, including onboarding of new study nurses and their training on Medidata system.
- Leading the transition of 3 thyroid eye disease pharmacology studies from North America to various European countries including IP release, study start-up and CRO.
Overseeing IP release after activation of study sites in Germany, Spain, France, and the UK, including Veeva Vault database research and filing of regulatory documents.
Erstellen von klinischen Bewertungen (Medizinprodukte Klasse 2b/3)
Clinical Affairs Specialist Role (2023): Writing of Clinical Evaluation Plan (CEP)
for energy devices as well as Project Coordinator Role (2023/2024) in Clinical
Operations (indication: ophthalmology) performing on program level, providing
administrative support for 3 international studies in chronic and non-chronic patients as
well as Open Label Ext. according to quality standards, taking the lead in EU-wide IP
release and start-up.
Remote Monitoring of eCRFs acc. to applicable standards
Ensuring audit readiness according to DIN EN ISO 9001
Creating and managing the trial master file
Preparing clinical evaluations of medical devices
Researching, evaluating and presenting scientific literature
Preparing reports in the context of post-market surveillance
Designing, translating and reviewing standard operating procedures
Submitting marketing authorization applications to ethics committees and ensuring
document workflow
Managing and translating essential documents both from German into English and from
English into German
Results and summary of relevant milestones:
Enabling a more time-efficient and economically more efficient procedure in the
context of applications for approval and submissions to authorities
Leading preparation of a trial master file audit
Created TMF checklists according to ICH-GCP (CSR Structure and Content) or TMF
reference model according to DIA (Drug Information Association)
Prepared/carried out QC of the paper-TMF of international trials
Reviewed the IMP return section of foreign centers
Examined the TMF regarding risk assessment and evaluation as well as GAP analysis
Supported and consulted the project lead
Delivered regular project-related reporting
Prepared reports to demonstrate and evaluate potential for improvement
Maintained and further developed existing systems
Coordinated idea management
Translated standard operating procedures (SOPs) from German into English
01/2021 - present Relevant recent start-up work in study start-up management and
administration (indication: breast cancer/blood disease) in Germany/Austria
Phase III: Randomized, double-blind, placebo-controlled multicenter study in
rare disease:
Assisting in preparing, compiling and submitting regulatory documentation of a Clinical
Phase III Trial in Rare Disease to Central Ethics Committee (Completion of CTAF Part A
and B) as well as regulatory submission to BASG (according to CT-1) in Austria
Carried out quality checks of translation of patient facing documents and creation of
surveys
Phase III: Randomized, open-label, international multicenter study in patients
with early breast cancer:
Identifying and selecting clinical trial sites
Assisting in clinical trial agreement and budget negotiation activities with sites
Activating clinical trial sites
Managing all site activation activities including:
Providing study materials and documents
Compiling documents required for site activation
Approving country/site level informed consents
Responsible for site level reporting
Phase II septic shock/sepsis trials:
Organizing international shipments
Filing of invoices and reports on SharePoint
Reviewing synopses
Writing of meeting minutes in German and English for steering committee meetings,
internal team meetings and study-specific team meetings
Regularly updating invoice trackers
Comparing cost proposals and TFLs in Spreadsheets
Responsible for general organization and planning of internal and external meetings
via GoToMeeting and Zoom
Overseeing database workflow
Translating SOPs
Survey of relevant former start-up work (oncology):
Investigative site recruitment including feasibility studies
Submitting regulatory authorities and ethics committees
Managing and translating essential documents from German to English and vice versa
Adapting informed consent forms
Electronic data capture (CTMS)
Writing meeting minutes, handling the communication between sponsor and CRO
Regularly updating invoice and budget trackers
Responsible for filing and workflow of essential documents in Documentum
Internally managing and acting as contact person for clinical research associates
In charge of on-site monitoring of visits and oversight
for energy devices as well as Project Coordinator Role (2023/2024) in Clinical
Operations (indication: ophthalmology) performing on program level, providing
administrative support for 3 international studies in chronic and non-chronic patients as
well as Open Label Ext. according to quality standards, taking the lead in EU-wide IP
release and start-up.
Remote Monitoring of eCRFs acc. to applicable standards
Ensuring audit readiness according to DIN EN ISO 9001
Creating and managing the trial master file
Preparing clinical evaluations of medical devices
Researching, evaluating and presenting scientific literature
Preparing reports in the context of post-market surveillance
Designing, translating and reviewing standard operating procedures
Submitting marketing authorization applications to ethics committees and ensuring
document workflow
Managing and translating essential documents both from German into English and from
English into German
Results and summary of relevant milestones:
Enabling a more time-efficient and economically more efficient procedure in the
context of applications for approval and submissions to authorities
Leading preparation of a trial master file audit
Created TMF checklists according to ICH-GCP (CSR Structure and Content) or TMF
reference model according to DIA (Drug Information Association)
Prepared/carried out QC of the paper-TMF of international trials
Reviewed the IMP return section of foreign centers
Examined the TMF regarding risk assessment and evaluation as well as GAP analysis
Supported and consulted the project lead
Delivered regular project-related reporting
Prepared reports to demonstrate and evaluate potential for improvement
Maintained and further developed existing systems
Coordinated idea management
Translated standard operating procedures (SOPs) from German into English
01/2021 - present Relevant recent start-up work in study start-up management and
administration (indication: breast cancer/blood disease) in Germany/Austria
Phase III: Randomized, double-blind, placebo-controlled multicenter study in
rare disease:
Assisting in preparing, compiling and submitting regulatory documentation of a Clinical
Phase III Trial in Rare Disease to Central Ethics Committee (Completion of CTAF Part A
and B) as well as regulatory submission to BASG (according to CT-1) in Austria
Carried out quality checks of translation of patient facing documents and creation of
surveys
Phase III: Randomized, open-label, international multicenter study in patients
with early breast cancer:
Identifying and selecting clinical trial sites
Assisting in clinical trial agreement and budget negotiation activities with sites
Activating clinical trial sites
Managing all site activation activities including:
Providing study materials and documents
Compiling documents required for site activation
Approving country/site level informed consents
Responsible for site level reporting
Phase II septic shock/sepsis trials:
Organizing international shipments
Filing of invoices and reports on SharePoint
Reviewing synopses
Writing of meeting minutes in German and English for steering committee meetings,
internal team meetings and study-specific team meetings
Regularly updating invoice trackers
Comparing cost proposals and TFLs in Spreadsheets
Responsible for general organization and planning of internal and external meetings
via GoToMeeting and Zoom
Overseeing database workflow
Translating SOPs
Survey of relevant former start-up work (oncology):
Investigative site recruitment including feasibility studies
Submitting regulatory authorities and ethics committees
Managing and translating essential documents from German to English and vice versa
Adapting informed consent forms
Electronic data capture (CTMS)
Writing meeting minutes, handling the communication between sponsor and CRO
Regularly updating invoice and budget trackers
Responsible for filing and workflow of essential documents in Documentum
Internally managing and acting as contact person for clinical research associates
In charge of on-site monitoring of visits and oversight