Senior Project Manager Clinical Operations, 60-100% (ID 2018)

Main Responsibilities

Project Management

• Plan and manage clinical studies within the framework of scientific and legal guidelines
• Manage the project portfolio of the assigned clients, coordinating all projects and activities of the assigned clients in order to assist them in achieving their strategic goals
• Support the clinical operations team to achieve strategic goals and improve internal processes
• Main contact person for budget development and budget tracking
• Provide training about budget development and tracking to the team members as required
• Prepare and coordinate and if required, conduct site initiation visits, monitoring visits and site close-out visits
• Coordinate the development of Clinical Investigation Plans, Case Report Forms and provide operational expertise as required 
• Coordinate and develop essential documents for the execution of clinical studies 
• Validation and control of quality of clinical data
• Compile and archive study documents 
• Periodically review study budgets 
• Provide status information on study data to AO ITC management and clients as required
• Maintain contact with Principal Investigators and Study Nurses 
• Evaluate clinical data in collaboration with the Biostatistician, the Medical Advisor and the Medical Writer 
• Generate budgets for studies and present them for approval to the clients 
• Define resource allocation for projects and inform other groups on resources required  
• Contractual negotiations with the study sites

In General

• Main contact person for clients 
• Represent AO ITC in Research Commissions 
• Planning and coordination of the annual research budget 
• Portfolio management, supervision and overview of dediacted research activities at AO ITC

Quality System

• The employee performs all tasks in alignment with the requirements of the ISO 9001 quality management standard and actively contributes to maintaining and improving the quality system.
• The employee undertakes additional responsibilities and duties as assigned by the line manager to support operational and organizational needs related to the Quality Management System.

Main Requirements

• Education: Master of Science (MSc), PhD in a scientific discipline or related healthcare field or equivalent training and experience.
• Minimum 2 - 3 years of experience in managing clinical trials/studies in a pharmaceutical, biotechnology, CRO and or healthcare setting including prior monitoring or equivalent experience
• Knowledgeable of clinical research operations, including interpretation and implementation of applicable regulations/ICH/GCP, ISO guidelines, is required 
• Demonstrates core understanding of medical terminology, methodological aspects of clinical trial activities
• Experience in interactions with outside and inside customers       
• Ability to work in complex or multiple projects and exercise critical thinking with minimal supervision   
• Solid attention to detail and excellent organization skills   
• Solid interpersonal skills and communication skills (both written and oral)   
• Ability to establish priorities, operate with a sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors 
• Demonstrates problem solving skills, demonstrates leadership skills, self-motivated and daptable to a dynamic environment 
• Flexibility and customer-focused mindset
• Proficiency in English, any other language will be considered as an added value