Clinical Trial Manager - Biotechnology Company - Autoimmune

• The Clinical trial Manager focusing on development of various programs: Phase I, II and III.
• Development & studies in the field of innate immunity and tissue repair

Informations sur l'entreprise

Our client is an innovative company with the objective of addressing important unmet medical needs in the areas of innate immunity, inflammation and organ/function repair.

Their expertise is focused on bone cell therapy and the therapeutic. They aim to become a leading company in the field of regenerative and immune medicine by developing innovative products for bone and autoimmune and inflammatory diseases.

With a broad and diverse portfolio of solutions in clinical development in a variety of therapeutic areas targeting markets characterized by significant unmet medical needs and limited innovation.

Missions

As the successful Clinical Trial Manager - Biotechnology Company - Autoimmune Era, you will have the following responsibilities:

• Carrying out and coordinating the clinical trial while ensuring:
• the rights, safety and protection of the patients enrolled in the clinical trials are respected
• the regulations in force, applicable SOPs and clinical study protocol are observed
• the collected data are real, accurate, exhaustive and consistent with the source data
• the objectives, schedules, deadlines and budget of the clinical trial are met
• Ensuring the communication with the sites of investigation and CROs
  
  
• Creation of the Clinical Study:
• Coordination of the writing and approval of the study documentation (clinical study protocol, statistical analysis plan, report forms, etc.)
• Review of the medical literature and new associate technologies in close collaboration with other departments (R&D, Regulatory, Production, QC, IP, etc.)
• Definition of the collection process of the Informed Consent Forms
• Coordination of the feasibility studies, responsibility for ensuring the selection, qualification and recruitment of the site study-team
  
  
• Implementation of the Clinical Study:
• Coordination of the trial preparation
• Site visits
• Management of the trial logistics
• Management of the Contract Research Organizations & services providers
• Project financial management
• Responsible for the clinical trial progress report
• Participation in the writing and review of the SOPs
  
  
• Coordination of the Clinical Study:
• Communication and development of a trust relationship with the sites of investigation
• Coordination of the study-related documentation filing made by the CRAs and CTA
• Management of the CSP amendments
• Coordination of the Data Base
• Coordination of the statistical activities and reports
• Coordination of the study report writing and its appendices

Profil du candidat

As the successful Clinical Trial Manager - Biotechnology Company - you will have the following requirements:

• At least an advanced degree (Bachelor/Master in Biomedical Sciences, Bioengineering, MD, PhD)
• At least 3 years' experience in clinical research and development or in the fundamental research field
• Experience within biotechnology or Pharmaceutical industries
• Knowledge of ICH-GCP
• Fluent in English - Advanced level in French or Dutch will be consider as a strong asset
• Common use of the Office tools
• Ability to work independently or in a team, strong interpersonal and communication skills
• Capacity to meet deadlines
• Proactive, dynamic and stress-resistant

Conditions et Avantages

As the successful Clinical Trial Manager - Biotechnology Company - you will have:

• An attractive complete salary package in line with your experience (Fix & Bonus system, Company Car, Net allowances, Insurances, etc.)
• The opportunoty to join a fast growing biotech with high ambition
• Integrate a large scale project with the opportunity to work on multiple project
• Participate in the growth and the development of a new research team
• A flexible work environment
• Potential to quickly grow toward people management responsibilities