eTMF Manager & Clinical Expert

• Senior Clinical Consultant with over 20 years of experience

• Familiar with Veeva and TransInteractive (eTMF) and very experienced in eTMF-Management (Veeva, Trial Interactive, etc.), eTMF Document Specialist, eTMF Archivist, Quality Control and Clinical Documents

• Very experienced in preparation for audits, in-house audits, as well as quality control for final completion reports as well as the supervision of clinical aspects of data cleansing and analysis

• Project experience covers Phase I-IV Studies in Germany, Austria and Switzerland across Neurology/CNS, Oncology, Cardiovascular, Rheumatology, Vaccine, Dermatology, Nephrology and Medical Device studies

Medical Devices:

• eTMF-Management (Veeva, Trial Interactive, etc.)

• EC/CA submission for pre-/post-marketing and in-vitro studies in Germany, Austria and Switzerland

• Preparation of all documents as e.g., ICF (adaptation acc. local regulations; translation)

• Submission in the electronic systems

• Oversee clinical aspects of timely data cleaning, data analysis; participate in data reviews

• Preparing and Negotiation of study site contracts

• Study Site Management (site qualification, initiation, monitoring, close-out)

• Technical support for intraoperative MRI scanner

Pharmaceutical Drugs:

• eTMF-Management (Veeva, Trial Interactive, etc.)

• Audit/Regulatory inspections (preparation-conduct -follow up)

• In-house Auditing

• EC, CA and BfS - Bundesamt für Strahlenschutz (Federal Office for Radiation Protection in Germany) submission for Phase I-IV Studies in Germany, Austria and Switzerland (adult and children)

• Preparation of all documents as e.g., ICF (adaptation acc. local regulations); subject questionnaires, subject diaries

• Regional Study Manager

• Project Coordination and Management of international clinical studies

• Lead feasibility assessment and selection of countries and sites for study conduct

• Define timelines and milestones

• ICH-GCP training of study team/Investigator

• Lead development of study plans and system set-up; protocol, CRF, ICF and other trial documents (e.g., CRF, Monitoring Guidelines, data cleaning plans, statistical analysis plans, vendor contracts, lab manual, IVRS)

• Oversee clinical aspects of timely data cleaning, data analysis; participate in data reviews

• Ensure appropriate response to new safety information (e.g., update of trial documents)

• Manage and lead cross-functional study teams, including vendors

• Contract preparation/negotiation for study sites

• Coordination of Investigator Meetings

• Interpretation of oncology, neurology, neurosurgery and orthopaedics imaging

• Quality control in relation for final report submission (consistency, readability and accuracy of documents)

• Quality control Management/ co-monitoring

• Drug label preparation

• Patient information leaflet/blister preparation

• CRO-oversight/co-visits

• eCRF design in accordance with the protocol

• Preparing of study site/vendor contracts

• Handling Study Safety data

• Monitoring report review

• Ensure Provide study specific training for internal and external (e.g., vendors, investigators) team members

• Mentor and role model for CRAs

• Co-monitoring with less experienced CRA’s or at challenging sites

• Study Site Management (site qualification, initiation, monitoring, close-out)

eTMF: Veeva, Trial Interactive

Therapeutic areas:

• Neurology/CNS

• Immunology/Hematology

• Gastroenterology

• Cardiovascular

• Orthopedics

• Rheumatology

• Oncology

• Vaccine

• Nephrology

• Endocrinology

• Dermatology

• Genetic disorder

• Pneumology

• Gynecology

• Ophthalmology

• Coordinate the end-to-end lifecycle of Veeva Vault eTMF System

• Ensure that Veeva Vault eTMF system is in compliance and fit for intended use in accordance with applicable Standard Operating Procedures (SOPs)

• Identify process inefficiencies and compliance gaps, participate in process improvement initiatives and drive process implementation

• Create Veeva Vault eTMF system generated reports as requested by stakeholders with a goal to improve eTMF compliance and quality

• Ensure Veeva Vault eTMF system meet internal and external quality standards and best practices

• Collaborate with clinical study teams in the preparation and follow-up for internal and/or external audits/inspections

• Provide consulting in eTMF system validation/migration/updates, improve eTMF functionality as needed, create and maintain robust eTMF processes and associated documents (SOP/Working Instructions etc.)

• Review and quality assurance of clinical trial documents

• Verification of completeness, accuracy and quality

• Cross-checking of documents

• Archiving documents in the eTMF system Audit preparation