Clinical Project Manager

  • Permanent
  • Geneva

Mission:

• The Clinical Project Manager (CPM) will participate at Spineart sponsored and supported clinical studies, by contributions from early phase of study preparation through study conduct and study closeout in compliance with Good Clinical Practices, and all National and Local Regulations.
• The successful candidate will act as study and project manager for studies of moderate to high complexity, ensuring high quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.
• Contributes to study protocol development.
• Interfaces with clinical data management and statistics in developing case report forms, managing data clean-up, and analysing study data.
• Develops project plan and budget/schedule in collaboration with other participants/contributors.
• Oversees site selection and training.
• Trains and oversees monitoring teams (CRAs) and the timeliness and quality of their work.
• Oversees study vendors (reference labs, CRO, other potential vendors).
• Obtains and reviews and approves study documents.
• Maintains study master file and all relevant study documentation. Performs study execution and status reporting activities.
• Oversee study closeout activities and contributes to the final clinical study report.
• Contributes to department/function continuous improvement activities/initiatives.

Profile:

• Medical or science education: Bachelor’s degree equivalent or higher qualification within Medicine, Bioengineering, Biological Science, Pharmacology or a relevant life sciences discipline
• Minimum 3 years of recent experience in clinical study management within medical device industry (Spine would be an advantage). Experience with class II & III medical devices preferred.
• Preferred experience includes clinical trials, post market studies, study monitoring, safety reporting, submissions, report writing, literature reviews, study budget management.
• Knowledge and experience of Good Clinical Practice (GCP) and regulations relating to medical device studies. Knowledge of additional/local regulations in different countries a plus.
• Project management skills required to include the use of a formal process and system for planning and tracking ongoing progress of clinical projects.
• CRO and other Vendor management experience is an advantage.
• Good communication skills including the ability to present complex information to both clinical and non- clinical disciplines.
• The Clinical Project Manager is expected to travel approximately 25% of the time.
• Fluency in English, any other language is an advantage.