Steenweg Deinze 150 Nazareth Belgium
Akcelis has recently been acquired by Pivotal. Pivotal is a leading therapeutically focused European CRO (Contract Research Organization) focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Your typical responsibilities might include:
Prepare and submit Competent Authority (CA) and Ethics Committees (ECs) packages to request clinical trial authorizations in Belgium, Netherlands, Luxemburg, and possibily other European countries. Those activites involve:
Ensuring the documentation submitted to ECs and CA is in compliance with applicable regulations;
QC translation of documents translated from English to the appropriate language, where required;
Translation of EC and CA queries from the local language to English, where applicable;
Collection of essential documents necessary for ECs approval from each selected site;
Preparation of ECs and CA answers to queries;
Submission of answers to ECs and CA queries, if applicable;
Participating in regular meetings with the local study teams and the Sponsor, where required.
Contract and budget negotiation with sites as needed;
Any other activity needed to obtain the required approvals for study start-up and site activitationin the concerned country/ies;
Any other regulatory activity needed for the conduct of a clinical study.
Ensure working procedures are performed in accordance with Pivotal and/or Sponsors´ SOPs, GCPs and national/international regulations.
Our office is located near Ghent, in Belgium
University Degree in life sciences area is desirable, not mandatory
Experience in clinical research at a CRO or a Pharmaceutical Company, as RA is desirable.
Sound knowledge of GCPs/ICH and international/local Regulations.
Updated knowledge of national/international regulations relative to Clinical Trial Start-Up procedures.
Organizational and planning skills.
High level of spoken and written English and other languages if required.
Good knowledge of current PC-applications.
Highly committed and ability to work under pressure.
Good communications skills.
Empathy and ability to establish good relationships with others.
An attractive salary in line with your experience
An in-depth insight into all moving parts of a growing company and professional development.
A job in a dynamic company with many challenges
Our company is growing and you can grow with us
No traffic jams, our office is based in Nazareth (near Ghent)
Please send your CV to firstname.lastname@example.org
Since foundation 18 years ago, Pivotal has been widely recognized as an EU-CRO with a solid internal medical franchise, that could act as “co-thinkers” for our clients (and not merely as “doers”), providing as well strategic advice in the complex clinical trials-landscape. Over the years, Pivotal has become an almost 200-strong boutique EU CRO (with >92% of employees are proper) and is legally incorporated in 12 countries across Europe, although can cover many more countries within EU – and has capacity to reach other regions worldwide via partnership with other similar trustful local CROs.