uniQure

Sr. Clinical Trial Associate (CTA) (Netherlands) - Amsterdam

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Job

Active since 10-08-2018 Job category Science, research & development
Location Amsterdam Level -
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
The Organization

uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Place in the Organization:

The Clinical Operations department is responsible for the management (planning, implementation, maintenance and close out) of the Clinical trials with a focus on the investigators (+ staff), regulations, compliance, timelines, data collection and review, and safety. Several tasks are outsourced to Clinical Research Organizations.

Purpose of the role:

The Sr. CTA will manage several aspects within the clinical trial, i.e. site & country management, vendor management. Next to that the sr. CTA is part of the cross functional project team and supports with all aspects of the clinical trial. The cross functional project team consist of research, pre-clinical, analytical development, CMC, Clin-Ops, RA, QA, Medical and Program Management.

Key result areas (major duties, accountabilities and responsibilities):

The Sr. CTA is a key member of the clinical trial team and contributes to all stages of the clinical development programs. From this position there is a potential to grow and develop yourself towards clinical trial management. Therefore, this position will require a pro-active mindset and a hands-on mentality. The Sr. CTA should be ready to be challenged and will be exposed to all aspects of clinical trial execution.

  • Clinical Trial Execution
  • Contact person / link between (some) study site(s) personnel, CRO(‘s) and other vendors
  • Support in designing study procedures and manuals
  • Support CRO in country and site selection, qualification and start-up procedures.
  • Provide country and site oversight during the execution of the trial, including accompanied site visits
  • Set up logistic organization, i.e. IMP or Lab
  • Review protocols, IB’s, CRF’s, SAP’s, tables/listings, statistical reports, study reports and publications
  • Participate in clinical development team(s)
  • Present study plans, updates and outcomes both internally and externally (e.g. during investigator meetings)
  • Controlling budget of studies
  • Support the management of the Trial Master File (TMF), i.e. set up and maintenance in line with ICH/GCP

Qualifications & Skills:

  • Minimum Bachelor’s degree; medical or related degree preferred
  • 3-5 years of relevant work experience
  • 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

Core competencies:

  • Accurate with an eye for detail
  • Enthusiastic and proactive attitude
  • Willing and able to travel when requested and necessary
  • Flexible and adaptive
  • Networking/Relationship 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
More information
This listing is a full-time job

Job category Science, research & development
Industry / Industries Biotechnology
Region Netherlands
Keywords Clinical Operations

Contact information

Name Marsha Lemmers

Location

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