inVentiv Health -Transforming Promising Ideas into Commercial Reality
Clinical Country Associate Belgium (ref 4995) – 0.8 fte
Are you an experienced Belgian CRA and looking for a next step? This might be the one!
We are currently looking for an enthusiastic clinical professional to join our Strategic Resourcing division. This means that you will be solely working for one of our pharmaceutical clients, while fully employed by inVentiv Health. This client is one of the world’s leading biotechnology companies and focusses mainly on neurological, autoimmune and rare diseases. In the role of Clinical Country Associate (CCA) you will be providing operational support to the Clinical Country Lead (CCL) in Belgium. In this position you will mainly be ensuring the GCO sponsor/CRO quality oversight activities in Wallonia, but also in Flandres. About two days a week you will be in the Diegem office and the rest of the week you will be out in the field. In all this you will be closely working together with a second CCA, who is mainly responsible for the Flanders area. Also you can be asked to assist colleagues in other European countries.
Overall you will ensure that all required operational activities are completed, enabling the CCL to focus on delivering the required operational and sceintific infomration to execute the overall development strategy in Belgium.
The CCA will allow for single point of contact for country level/cross study activities relating to local ‘sponsor’ relationships, management of internal and external stakeholders, oversight of CRO and country level performance, and provide local information, resource and communication capabilities to maximize information flow in order to highlight and mitigate potential issues and efficiently resolve active issues.
The key responsibilities of the CCA are:
* Under the operational direction of CCL, perform GCO defined, country, site, and CRO sponsor oversight activities, including SOVs, to ensure high quality execution of clinical trials and highlight local opportunities to drive operational excellence. [30%]
* For assigned studies or sites, act as primary country level ‘GCO ‘sponsor’ contact, establishing and maintaining excellent working relationships with local CRO staff and ensuring aligned, appropriate and timely exchange of information and resolution of escalated issues between all stakeholders. This may include attendance at site visits outside of SOVs (e.g. SIVs, SSVs). [30%]
* For assigned studies or sites, CCA works with the CCL, Strategic partner CRO, and global teams to provide required information (e.g. Medical and Operational Assessment) as part of defined country and site selection processes. [20%]
* Support CCL in maintaining accurate contact lists, calendar information, local clinical operational intelligence (including regulatory) and update tracking systems as needed. [15%]
* Other assigned activities per CCL delegation and assignment, CCM all-hands meeting. This can also include direction given from your inVentiv Health Clinical Line Manager. Trainings, etc. [5%]
This role is offered through a contract of inVentiv Health Belgium with full benefits like 13th month, car allowance, lunch vouchers, ecocheques, etc.
If you have the required experience for this position, please send your application with full CV with reference to job number 4995
If this role is not suitable for your experience but you have worked in clinical research in the industry and would like to discuss other roles, please contact us as well for other possibilities!
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry deliver new drugs and therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) is made up of more than 14,000 employees who have the ability to service clients in more than 90 countries.
We offer a differentiated set of solutions designed to improve client performance and accelerate the process of bringing products to market. For more information, visit inVentivHealth.com
Experience and Education Required:
* Enthusiastic about being in the field
* Excellent in building up and maintaining site relationships
* Minimum three years clinical trial experience, at least the level of a senior CRA
* Experience working with outsourced models is preferred
* Good scientific knowledge to be able to hold informed discussions on compound, development plans, protocol, endpoints with investigator site personnel
* Native French and very good knowledge of Dutch and English
* Very good communication skills
* Willing to travel, as cross border activities may be required
* Flexible and pro-active