Freelance Consultant Clinical Trial Management (m/f/d)

Clinical Trial Management (m/w/d)

Clinical Operations Study Management in Global Oncology Medical Affairs:

• Company Sponsored Interventional Studies (CSIS), Non-interventional Studies (NIS) & other medical research projects (including pathologists training and education, assay concordance, or digital/AI pathology)
• Responsible for the preparation, set-up, and execution and reporting of all clinical trial activities, ensuring adherence to timelines, budgets, project and quality plans, and relevant ICH/GCP Guidelines

Vendor/CRO/Supplier Management:

• Facilitate the creation of requests for proposal and contribute to the selection of vendors/ suppliers / CROs
• Responsible for management and oversight of CRO(s) and vendors performance to ensure adherence to scope of work within timelines and budget at an overall study level with highest quality

Process/Policies/Compliance:

• Consult on the development of clinical operations related Corrective and Preventative Action (CAPA) plans for issues of non-compliance if applicable

Skills:

• University/Master’s degree in life sciences preferred with a minimum of 6 years of experience in Clinical Operations in the pharmaceutical industry or CRO is required
• Experience in global clinical study settings and in Medical Affairs required
• Experience in the operational execution of interventional and non-interventional studies in a Medical Affairs environment required.
• Experience in the operational execution of diagnostic medical research projects including pathologists training and education, assay concordance, or digital/AI pathology beneficial.
• Fluent English (oral and written)
• Proficiency in computer applications such as Microsoft Word, Excel, PowerPoint and Project as well as other relevant platforms related to clinical operations