Senior Manager of Clinical Trials
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Clinical Research and Pharmaceutical organization, based in Netherlands.
Our client is keen on improving the living standards and the vitality of people their lives. Treatment, prevention and care are central in treating the challenges of high demanding ailments. Knowledge is the center core of this company
ROLE DESCRIPTION
You will lead the international and regional coordination of clinical trial management projects by trials that are directed from internal and external. You will manage the study management team and be closely involved with the clinical operations team. You will be key person in the central clinical trials team and collaborate intensively with the global trail leader
RESPONSIBILITIES
-Manage regional/global clinical operations deliverables against project timelines. Support GTL in managing global vendors involved in site facing work; -including country & site feasibility, site selection, trial set-up, study execution and set up and closure activities as assigned.
-Manage country budgets and monitor against forecasts for Out of Pocket Expenses, and review assigned vendor invoices/spend.
-Manage enrolment success factors and ensure delivery of projected commitments across the regions at the clinical trial level.
-Deliver study-specific documents such as Monitoring Guidelines, Informed Consent Form, Blinding Plan, country and site feasibility related documents.
Provide input into cross functional documents i.e. Safety related documents, Protocol Deviations and Issue management processes
-Create , communicate and deliver trial training materials to the GCO site study staff
REQUIREMENTS
-BSc or higher at University level
-Plus 8 years of experience in the management of clinical research trials in a CRO or a pharmaceutical company
-Strong communication, planning and management skills and knowledge of clinical operations
-Able to perform with not much direction
-Excellent language skills concerning English
-Providing training to the junior staff
-Willing to travel more than 20% of the time
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Hanneke de Koning.
