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