Description
For our client, a leading multinational company, we are searching for a Site Manager to work in The Netherlands (South) or Belgium for 6 months + possible extensions.
Your responsibilities will include the following:
- Manage investigational sites in Belgium, The Netherlands and Luxemburg for specified Phase 1-3 trials ensuring compliance with protocol, company SOP's, 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
Education and skills
- Medical, para-medical or other biologically 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 activities of the investigational site staff and to contribute to the local Clinical GCO trial team
- Have good command of spoken and written Dutch, French and English, cultivate excellent relations with investigational site staff and be a proactive, enthusiastic member if the local Clinical Trial 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 SOP's, ICH-GCP, (where appropriate, European) and local national regulations
- Willingness to travel with occasional overnight stay away from home
If you are interested in this position, please respond within 24 hours with your CV in Word format so MBA can contact you. MBA do have a policy to fulfil job requests within 24 hours therefore a quick response is important.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.