Associate Portal and Process Manager

With over 25 years in the pharmaceutical industry, she excels in international clinical operations, ensuring projects stay on track despite challenges. Track record for CTA submissions according to the EU Clinical Trials Regulation (EU) No 536/2014

Proven expertise in managing clinical trials from planning to archiving, including CTA submissions, monitoring, and QA/QC support, with a focus on regulatory compliance

Led multi-country clinical trials, managing teams and ensuring timely submissions and approvals, while developing processes for ASR and SoR submissions to CTIS

Holds a PhD in Biology, with extensive experience in research and clinical trial management, fluent in German and English, and proficient in various clinical trial management systems

Clinical trial management, from planning phase to archiving

CTA submissions according to the EU Clinical Trials Regulation (EU) No 536/2014

Monitoring, QA/QC support, Process set up

Preparation and submission of clinical trial dossiers (Phase 1 up to multi-country Phase 3 trials) to the EMA Clinical Trials Information System (CTIS), life cycle management in CTIS, notifications of regular and irregular trial dates according to the EU Clinical Trials Regulation (EU) No 536/2014 ensuring smooth and in-time submissions, approvals, and start of the trials

Accountable for submission of Annual Safety Reports (ASRs) and Summary of Results (SoR)/Layperson’s Summary of Results (LS) ensuring the sponsor’s reporting obligations were met

Lead portal manager for multi-country trials (up to 22 countries and 480 sites) leading teams of up to 8 supporting portal managers successfully meeting the submission timelines

Set up of processes for ASR and SoR/LS submissions to CTIS, creation of process flowcharts and guidance documents, training for future use by the company

Accountable for planning, execution, and oversight of clinical trials, Phases 1, 2 & 2/3, from set up to archiving (anti-infectives & immune modulator / USA, DE, AT, SA)

Selection and oversight of external vendors/suppliers and trial sites, including request for proposal (RFI) process, contract negotiation, budget planning and tracking, review and release of invoices - ensuring selection of best suitable vendors and correctness of invoices and payments

Successful lead of clinical trial teams (internal and external experts), internal team meetings and regular vendor calls, regular process reports

Preparation, review, processing and QC of CTPs, IBs, ICFs, SAPs, diverse manuals, plans and specifications (patient recruitment and retention, monitoring, data management, IXRS, EDC, laboratories, photography vendor, DSMB, etc.) and clinical trial applications (CTAs)

Accountable for IMP distribution, return, and overall accountability

QC of preclinical documents, reports, and other documents for submission to CAs

Monitoring and oversight visits, ensuring relevant monitoring quality

Responsible for operationally setting up a retrospective chart review study (USA) that provides required information for the company’s future development plans

Operational interface for sites regarding US emergency IND cases

Support of the company’s overall grant project manager, providing CTM input from the sponsor’s perspective to a retrospective study in cooperation with academic partners, ensuring relevant standards are met for obtaining high-quality data, and finally leading to various publications

Writing and review of SOPs and associated templates, which built relevant parts of the company’s QA system

Training of junior colleagues regarding monitoring and clinical trial management tasks, enabling them to take over increasing responsibilities