Your new role
In this role as (Sr.) Clinical Trial Associate (Sr. CTA) you are a member of the global Clinical Operations Department. The Clinical Operations department is responsible for the management and execution (planning, implementation, maintenance and close out) of clinical trials with a focus on the investigators (+ staff), regulations, compliance, timelines, data collection and review, and safety reporting. You will be a valuable member of the team who is contributing both independently as well as part of a team to bring creative ideas and solutions to a project. From this position there is the opportunity to grow into clinical trial management. This position requires a pro-active mindset, hands-on mentality and minimal instruction on daily tasks.

On a daily basis, you will be responsible for:

• Authoring/editing of study documents/plans in addition to tracking versions
• Reviewing essential regulatory document packages from clinical sites in order to approve Investigational Medicinal Product release or initiate study activation, per relevant SOP
• Set-up and management of the TMF for assigned study/studies as appropriate. Always conscious about having an inspection ready TMF
• Serving as a back-up to the CTM when needed
• Reviewing protocols, CRF data, lab data, tables/listings, study reports and publications and identifies issues and recommends solutions, and provides analysis of data in graphical formats as needed
• Being primary contact between (some) study site(s) personnel, CRO(‘s) and other vendors
• Setting up project team meetings, distribute agendas, record and finalizes meeting minutes, collate presentations
• Performing monitoring report review and following up on action items as necessary, in addition to managing the metrics for reports per the study monitoring plan
• Independently identifying areas where tracking study related activities or data may be necessary
• Communicating with legal on contract/CDA negotiations with vendors and sites, CMF forms and tracks the status of such documents
• Managing project specific financials (change orders, invoices, budgets)
• Obtaining clinical trial insurance including renewal sand cost
• Communicating with sites/CRO regarding regulatory document questions and reviews as appropriate
• Providing country and site oversight during the execution of the trial, including accompanied site visits if needed
• Setting up, tracking and managing study logistics as needed (i.e., lab sample traceability; supplies; study document annual dates)
• Initiating and/or contributing to special projects for clinical operation department initiatives
• Contributing to or initiating process improvement and sharing information/knowledge with staff
• Performing job responsibilities in accordance with quality standards and ICH/GCP principles

Your profile

• Bachelor’s degree; medical/science or related degree preferred
• 3-5 years of relevant industry experience in similar/relevant job (CRO, Sponsor or Clinical/Academia setting)
• Strong organizational skills, and effective communication across all levels within an organization
• Solid understanding of the responsibilities and needs of other functions in a clinical trial
• Computer skills: recent and active knowledge of MS Office applications
• Extensive knowledge of current ICH-GCP regulations, knowledge of ATMP preferred
• Fluent in English, verbal and written

• Accurate with an eye for detail
• Independent thinker/doer
• Enthusiastic and proactive attitude
• Willing and able to travel when requested and necessary
• Flexible and must be comfortable working in a fast-paced environment with a demonstrated ability to manage multiple competing tasks and demands
• Networking/Relationship and Vendor management
• Development: Learning orientated and able to continuously self-improve
• Able to think creatively and provide innovative solutions to (non-)standard problems.
• Capable to solve day-to-day problems and to take responsibility for decisions.
• Able to work with/around sensitive and confidential information

About the organization
Your new company is based in the Amsterdam area and focuses on making the future of medicine better using gene therapy. By doing so, they help patients with serious unfulfilled medical needs. This means that you will, indirectly, contribute to helping those patients and potentially giving them a better life. On a daily basis you will contribute to this as well. The company is continuously looking for highly motivated and skilled people who are willing to make a difference.

The benefits
You will work in an international and dynamic environment with many opportunities to grow your career for the long term. The salary depends on your education and experience and they offer great secondary benefits, such as 30 holidays, travel expenses, stock options, a good pension scheme, a monthly allowance for your health insurance, an annual personal education budget and a company fitness plan. It’s an amazing environment, will you join them as a (Sr.) Clinical Trial Associate?

What you need to do now
Are you interested in this vacancy as (Sr.) Clinical Trial Associate ? Click on 'Apply' and send an up-to-date CV or call Merel Hasselo on +31620076590. If this vacancy is not exactly what you are looking for, but you are looking for a different position, please contact us for a confidential discussion about your career options. #1046098