We are actively recruiting for a Clinical Research Program Manager

This position will take the lead for a new clinical research program at TISSIUM with global impact. The Clinical Research Program Manager will work closely with product development teams and cultivate relationships with key external collaborators. Key job aspects include development of strategies for clinical evidence dissemination, clinical study design, and driving processes to meet program milestones in alignment with TISSIUM’s business objectives.

Duties & Responsibilities

• Oversee, design, plan, and develop clinical research strategies for successful clinical development programs
• Prepare and author protocols and core clinical study documents
• Interpret clinical study results
• Develop evidence dissemination plans, and support development of publications and presentation materials
• Develop and manage clinical study budgets
• Vendor selection and management
• Support development of clinical messaging
• Oversee advisory boards to develop clinical strategy
• Represent Clinical Affairs on product development teams
• Collaborate across functions internally and externally to ensure program execution to achieve business goals.

Qualifications & Skills

• Bachelor’s degree with a minimum of 7 years of clinical research experience with medical devices, drugs, or biologics or advanced degree with a minimum of 5 years of clinical research experience with medical devices, drugs, or biologics.
• Experience developing clinical strategies and study designs.
• Basic understanding of biostatistics.
• Budget development and management.
• Excellent project management and organization skills.
• Experience in technical writing of clinical evidence reports, scientific manuscripts, and summaries of safety and clinical performance.
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical studies, such as ISO14155.
• Excellent spoken and written English.
• Knowledge of French is helpful, though not required.

Comptences & Personal Attributes

• Autonomous and detailed
• Strong operational management skills
• Dynamic and proactive
• • Ability to travel internationally
• Disciplined and organized
• Persuasive and diplomatic