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 and support logistic organization, i.e. IMP or Lab
- Review protocols, IB’s, CRF’s, SAP’s, tables/listings, statistical reports, study reports and publications as needed
- Participate in clinical development team(s)
- Assist the Clinical Trial Manager/Director with timeline maintenance and overall study needs
- Present study plans, updates and outcomes both internally and externally (e.g. during investigator meetings)
- Assist/Manage with budget of studies or ancillary vendors
- Support the management, tracking and QC of the Trial Master File (TMF), i.e. set up and maintenance in line with ICH/GCP
- Minimum Bachelor’s degree; medical or related degree preferred
- 2-5 years of relevant industry experience within clinical development
- 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
Your 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
For more information please contact me at: +31 (0)20 20 44 502 or email@example.com.