Medpace

Manager

• End-to-end management of the clinical trial agreement (CTA) process for global, multi-site clinical trials
• Develop the study-specific CTA strategy with the Sponsor and internal stakeholders
• Develop country-specific CTA templates
• Negotiate CTAs and the corresponding budget directly with sites
• Present progress to internal and external stakeholders ensuring deliverables are met within agreed upon timelines.

Senior Contract Manager

Clinical Research

• Contribute to clinical development of plan preparation
• Review of study protocol and preparation of statistical methodologies
• Programming of study analysis, review of study results and preparation of statistical methods section for clinical / statistical reports
• Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis
• Communicate statistical results to medical writing personnel to ensure accurate interpretation

Virtual Biostatistician – PhD Statistics/Biostatistics

• Travelling to study sites (Germany-wide) to conduct qualification, initiation, monitoring, and closeout visits in compliance with the approved protocol
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
• Verification that the investigator is enrolling only eligible subjects
• Regulatory document review
• Medical device and/or investigational product/drug accountability and inventory
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Senior Contract Manager

Virtual Biostatistician – PhD Statistics/Biostatistics

Clinical Research Associate, Virtual Event