Vacature Site Manager (CRA) - Nederland
Functie: Clinical Research Associate
Regio: Nederland
Bedrijfomschrijving
This innovative farmaceutical company provides medicines for an array of health concerns in several therapeutic areas and is one of the world's leading healthcare corporations.
Functieomschrijving
- Manage investigational sites in Belgium, the Netherlands and Luxemburg for specified Phase 1-3 trials ensuring compliance with protocol, Company SOPs, ICH-GCP and national regulatory requirements, local patient recruitment targets and financial agreements
- Perform all trial-specific duties and activities assigned according to the current list of Roles and Responsibilities
- Ensure accuracy, validity and completeness of data collected at investigational sites, that meet clinical objectives and protect patient safety
- Primary local Company contact point for investigational site, monitoring and managing site activities on a daily basis
- Prepare and submit Visit Reports punctually to Local Trial Manager for review
- Report directly to a functional manager
- Perform and coordinate ongoing trial-specific training for investigational site staff
- Assist in training of Company staff as required Place in the organization
Functie-eisen
- medical, para-medical or other biologically related scientific education at university level
- Experience and proficiency in the conduct of clinical trials
- Knowledge of clinical drug development and regulatory processes and procedures within GCO Clinical Trials
- Ability to manage and support the activities of the investigational site staff and to contribute to the local GCO trial team
- Good command of spoken and written Dutch, French and English
- Cultivate excellent relations with investigational site staff and be a proactive, enthusiastic member of the local Clinical Trials team
- Ability to organize multiple priorities and projects within area of responsibility
- Understand and use a range of computer-based systems to track, monitor and report on investigational site activity and status
- Ability to anticipate and resolve investigational site-related problems
- Possess a thorough knowledge of and comply with Company SOPs, ICH-GCP, (where appropriate, European) and local national regulations
- Willingness to travel with occasional overnight stay away from home
Solliciteren
Heb jij interesse in deze functie als Site Manager (CRA) voor Nederland?
Neem dan contact op met Irene Houtsma 
via onderstaande sollicatie knop of bel naar 038-455 62 62..
