Clinical Project Manager / Clinical Study Lead

Over the past 12 months, Apsida have been partnering one of the most exciting biotechnology companies in Germany where we have been building their Clinical, Medical, Regulatory and CMC teams. They are progressing their lead development programme in to a pivotal Phase III study therefore I am working with the VP Clinical and Clinical Operations Program Lead to find an experienced Clinical Project Manager/Clinical Study Lead in Germany.

This biotech have done many interesting studies in several promising directions with strong designs, endpoints, and safety data. The management team are fantastic, highly experienced and have built a great company atmosphere. The candidates we have placed their are all very happy with their new roles!

Responsibilities

• Oversee, direct and lead all project-related clinical operations activities for this project
• Lead the preparation of a Phase 3 trial (CNS) in collaboration with the CRO (protocol development, performing site/country qualifications, and regulatory submissions), medical consultants and experts, and with regulatory consultants
• Provide sponsor oversight of all activities
• Oversee the project budget
• Interacting with medical experts and the Steering Committee
• Can be a 80%-100% FTE position

Requirements

• At least 3 years of experience of Clinical Project Management
• Phase II/III experience as a CTM/CPM/CSM
• CNS experience advantageous but not essential
• Ability to work well in a dynamic, entrepreneurial, small biotech environment
• Self motivated, pro-active person
• Fluent in English with the ability to communicate accurately and effectively in verbal and written form (German language skills are optional)

If this opportunity interests you and you would like to find out more information, please contact me directly via this advert or email me via alex.coppen@apsida.co.uk