As an experienced Clinical Trials Project Manager in the Research Operations Team, you will have the oversight of all study activities related to the set-up and coordination of international clinical studies (Phase II / III) or research programs internally, and with external partners. You will be based in Brussels, Belgium, report to a Project Management Leader / Research Operations Director.
Main activities are:
Serve as main study contact for operational activities for the customer, with multiple partners, including customer member groups, pharmaceutical industry partners, and a variety of vendors for the clinical trials or research programs.
Coordinate customer responsibilities for individual clinical trials, including, but not limited to:
Conduct of group / site feasibility surveys
Set up of study governance committees and related documentation
Coordination of governance committees and working groups and their meetings (including taking minutes)
Development and follow up on study contracts and budgets in collaboration with the customer Legal and Finance departments
Prepare, manage and follow-up on internal and external meetings between partners (including taking minutes)
Lead internal and external discussions related to operational activities of assigned studies
Prepare and/or review study documents and communications
Assist in preparation and follow-up of study related grants if needed
Other scientific operations activities as needed
Ensure that customer principles and processes are adhered to, under the guidance of Project Management Leaders/Research Operations Director
Maintain customer study / program files and assist with administrative tasks as needed.
Contribute to the improvement of all processes and procedures and all related customer documentation.
Qualifications
Academic degree, preferably in a (para)medical discipline
Experience in the set-up and management of all operational aspects of clinical trials (in academia, industry, or CRO)
A good knowledge of GCP and methodologies, regulations and procedures related to clinical trials
Experience in oncology clinical trials is a plus
Previous experience in managing budgets and contracts is a plus.
Strong analytical, organization, planning and communication skills
Ability to:
work effectively in multicultural teams within customer's headquarters and the customer's network, and across organisational boundaries, respecting differences between people from a variety of linguistic and cultural backgrounds
learn, interpret and apply a variety of complex policies and procedures with minimal guidance
accurately and professionally process a high volume of correspondence, documents and other often sensitive and confidential information
maintain a high level of poise and professionalism while coordinating a diverse variety of daily and special project deadlines simultaneously
Native or native-like written and spoken English; French, Dutch or other languages are a plus
A high level of integrity and sense of responsibility and professionalism
What we offer:
We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers , eco vouchers, mobile phone (data included)We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)
Side activities will be organised regularly, to achieve a close collaboration within our team
We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
We contribute to a number of charities & support the research and / or the patients in our industry.