Site Manager

Hobson Prior are currently seeking a Site Manager to join a brilliant pharmaceutical organisation on a permanent basis located in Antwerp. Our client is focused on being capable to distribute accessible and affordable remedies to help produce a healthier society.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will be accountable for contributing to quality Site Selection through partaking in site practicability and/or pre-trial site assessment visits, offering recommendations from local area about site/investigator selection in alliance with the trial team, as needed.
• You will initiate study compliance by implementing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies. Guarantee site staff are qualified and the consistent training records are complete and precise at any time point during all trial phases.
• Participate in site level recruitment strategy and contingency preparation and application in partnership with other functional areas to reach clinical research target.
• Act as main point of company contact for allotted trial sites, engaging with Investigator and Site Staff during the life of the trial (investigator meetings, site visits, quality communication, etc.).
• Warrant site is equipped to carry out the trial with suitable site study supplies (such as Non-IP, lab kits, etc.) and clinical drug supplies. This will involve oversight of proper handling, storage and return and/or destruction with exact inventory maintained/documented.
• As the Site Manager, you will guarantee quality data (accurate, valid and complete) is offered by the site and questions resolved within anticipated timelines.
• Certify trial subject safety in that all AEs/SAEs/PQCs are reported within the essential reporting timelines and documented as suitable, with supporting data collected and certifiable with information in the source documents.
• The ideal candidate will ensure Inspection readiness for sites by maintaining finished, precise and timely data and vital documents in systems utilised for trial management (e.g. CTMS and eTMF/IF) according to potentials (metrics) and archiving retention requirements, including storage in a protected area at all times.
• Any other assigned duties.

Key Skills:

• Solid IT skills in fitting software and company systems.
• Effective communication skills, oral and written.

Requirements:

• Acquired a BA/BS degree/Degree in a health or science associated topic or similar industry experience.
• At least 2 years of clinical trial monitoring experience or corresponding industry experience and completion of a monitoring training course.
• Advanced: at least 3 to 5+ years of clinical trial monitoring experience.
• Explicit therapeutic area experience reliant on the services need.
• Solid operating knowledge of ICH GCP, company standard working procedures, local laws and regulations, allocated protocols and linked protocol specific procedures involving monitoring guidelines.
• A willingness to travel with overnight stay away from home when necessary.
• Capable in speaking and writing in English and the country language where services will be delivered.
• Former experience with monitoring and site management of complex Early Phase of clinical development, as pertinent.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.