Clinical Operations Manager

• Enthusiastic Clinical Operations Professional, specialized in Cell Therapies and Oncology, wants to drive innovations with potential to cover unmet medical needs of cancer patients

• Responsibility in local clinical trial leadership of several clinical trials, Responsibility for ensuring processes, protocols, service levels, and quality meet and exceed established clinical standards

• We have recruited him previously and consistently received outstanding feedback across all professional competencies, as well as interpersonal and communication skills

• Responsibility and global clinical operations leadership of complex trials, coordination of sponsor overview activities

• Highly skilled in all typical activities of sponsor oversight, experience gained from projects with sponsors (big, medium, small) and CROs

• We have recruited him previously and consistently received outstanding feedback across all professional competencies, as well as interpersonal and communication skills

Therapeutic area: Acute Pancreatitis

• Responsibility & consulting for clinical trial operations of clinical trials phase I

• Process set-up, Project Budget set-up & management

• Monitoring of Clinical Operations, and study-specific Objectives and KPIs

Indications: Non-small Cell Lung Cancer, HER2-overexpressing Gastric Cancer, Hepatocellular Carcinoma, Multiple Myeloma

• Responsibility in local clinical trial leadership of several clinical trials (stages I & III)

• Responsibility for ensuring processes, protocols, service levels, and quality meet and exceed established clinical standards

• Project Budget set-up & management

• Set-up and maintenance of patient engagement structures

• Monitoring of Clinical Operations and study-specific Objectives and KPIs

Indication: Multiple Myeloma

• Responsibility and global clinical leadership of a phase I clinical trial

• Resourcing of projects, oversight of employees’ appropriate role-based training

• Evaluation of the work of Clinical Operations staff

• Preparation of contingency plans to accommodate project specifications and targets • Setting overall direction, strategy, and performance standards for Clinical Operations teams

• Providing guidance on quality metrics to align with company objectives

• AI-assisted design, set-up, and maintenance of patient engagement structures

• Coordination of appropriate role-based training to all Clinical Operations staff, including oversight of the execution of the training plan

• Monitoring of Clinical Operations and study-specific Objectives and KPIs

Indications: Breast cancer, Bladder Cancer, Non-small Cell Lung Cancer

• Responsibility and global clinical operations leadership of a phase I cell therapy clinical trial with TCR-modified T-Cells

• Providing Clinical Operation support to CDx development, German Radiation Board

• Coordination and Execution of Clinical Trial submission activities

• Organizational lead in Investigator Meeting organization

• Set up of Clinical Studies, Vendor selection, including bid defense activities

• Creation and implementation of Standard Operating Procedures

• Coordination of Risk Management for Clinical Studies

• Coordination of application to competent authorities

• Coordination of submissions to ethics committees, Site Contract negotiation, Coordination of sponsor overview activities

• ATMP Clinical Trial Implementation: Coordination in Georgia

• Oversight of EU/non-EU cross-border activities

• Set up and overview of Clinical Studies at research clinics

• Creation and implementation of Standard Operating Procedures

• Coordination of Risk Management for Clinical Study sites

• Coordination of application to competent authorities

• Coordination of submissions to ethics committees, Study Site Contract negotiation

Indications: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Multiple Myeloma

• Development from Clinical Research Associate role to Clinical Trial Manager role

• Responsibility and global clinical operations leadership of a phase I cell therapy clinical trial with TCR-modified T-Cells

• Set up of Phase I Clinical Studies & Coordination of sponsor overview activities

• Vendor selection, including bid defense activities

• Coordination of Risk Management for Clinical Studies