Statistical Analysis

SAS, SPSS, R

Data / Document Structure

XML, HTML, CDICS-ODM, DIA-Reference Model

Clinical Trial Systems (selection)

• CTMS
• eCRF (e.g. Rave, Marvin, InForm)
• eTMF (e.g. Veeva Vault)
• Clinical Sample Testing Services (e.g. Covance, Quintiles)
• XIVRS (e.g. Almac, ClinPhone)

Experiences Clinical Trials:

CRA(Clinical Research Associate) -> Refer to last page for Project List

• Performed essential document Investigator Site File reconciliation and review.
• Updated applicable tracking systems of the clinical trial study team.
• Escalated site and trial related issues per SOPs, until identified issues are resolved or closed. Reviewed and verified accuracy of clinical trial data collected, either onsite or remotely. Communicated with investigator sites.
• Assessed IP accountability, dispensation and compliance at investigator site.
• Completed monitoring activity documents as required by SOPs or other contractual obligations. Prepared Investigator Site File.
• Reviewed and quality checked Investigator Site File before sending to site.
• Provided and maintained Investigator Site File checklists for CRAs. Processed, reconciled, distributed and tracked essential documents.
• Ensured serious Adverse Events (SAE) reporting according to project specifications.
• Trained site staff if requested and necessary and ensure all required training of site staff is completed, documented and filed in Investigator Site File.
• Conducted Routine Monitoring Visits, Remote Monitoring Visits, Site Initiation Visits, Close Out
• Visits and blinded Monitoring Visits in accordance with company SOPs.
• Monitored sites to ensure trials are conducted in compliance with ICH-GCP guidelines and relevant SOPs.
• Performed source document verification, retrieves case report forms and performs query resolution and oversees drug accountability and safety at investigator site.
• Collected essential documents for Trial Master File (TMF).
• Phase: I-IV; NIS
• Indication: Oncology / Hematology
• Country: Germany, Austria, Sweden

TMF (Trial Master File)

• Supported Project Managers and study teams in executing assigned clinical trial activities (e.g. creating and maintenance of trackers, issue listings)
• Created and maintained TMF metrics and spreadsheets
• Served as main administrator of the TMF
• Indexed documents of TMF
• Performed set up of TMF
• Managed documents and ensure they are quality checked, correctly filed and complete in TMF
• Performed regularly review and quality checks of TMF
• Escalated TMF quality issues to relevant parties (e.g. project team)
• Communicated with project team members to assess project needs relevant to the TMF
• Wrote TMF guidelines (e.g. Filing of regulatory documents, indexing)
• Contributed to the continuous development and implementation of TMF related procedures
• Reconstructed of TMF
• Provided Status Report of TMF
• Type of TMF: Paper TMF and eTMF (DIA - TMF Reference Model)

Site Management Associate (SMA) / Clincial Trial Assistance (CTA)

• Set up and maintained study documentation in applicable systems, e.g. Clinical Trial Management System (CTMS), TMF system, applicable site / sponsor systems according to project protocol, applicable SOPs and project plans.
• Performed Off-Site Monitoring Visits.
• Verified Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines.
• Communicated with investigator sites, updated applicable tracking systems, ensured all site required training is completed and documented in a timely manner.
• Remotely assessed IP accountability and temperature excursions and compliance by the site.
• Worked in conjunction with CRA to implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines.
• Assisted management with the development of process documents and training materials.
• Performed and documented clinical data review and query creation, query resolution, offsite central monitoring contacts / visits and site management communications as outlined.
• Completed submissions and notifications to local regulatory authorities and local ethics committee.
• Performed a variety of routine essential document collection, review, negotiation, to ensure successful maintenance and close out tasks under general supervision.
• Prepared, maintained and shipped clinical study supplies and documents to study sites, sponsor and vendors.

Investigator Payments

• Organized and maintained investigator payments Europe-wide
• Performed tracking of investigator payments
• Prepared payment information regarding investigators fees
• Processed invoices
• Acted as contact person for investigator payments
• Developed and implemented investigator payment processes

Medical Writing

• Wrote Final Study Reports for post-marketing studies.
• Prepared and supported final statistical analysis for post-marketing studies.

Study Coordinator

• Study Coordinator for more than 20 clinical trials
• Performed training of Study Nurses
• Developed, programmed, implemented and maintained a Site Management System
• Implemented finance management for clinical trials
• Performed finance management of clinical trials
• Supported contracts of clinical trial
• Implemented an archiving process for clinical trials