
Country Start-Up Expert
2 days ago
Syneos Health is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
About the Role
We are seeking a highly skilled Country Start-Up Expert to join our team. As a key member of our Site Activation department, you will be responsible for acting as Subject Matter Expert for in-country performance within the Site Start-Up, acting as country-level intelligence on start-up (SU) and clinical trial regulatory (CTR).
Responsibilities
- Acts as Subject Matter Expert for in-country performance within the Site Start-Up.
- Acts as country-level intelligence on start-up (SU) and clinical trial regulatory (CTR).
- Ensures local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository.
- Provides clear data protection guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements.
Requirements
- Bachelor's Degree, preferably in a science field.
- Minimum of 3.5 years' experience as a country start-up specialist.
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
- Good understanding of clinical protocols and associated study specifications.
- Excellent understanding of clinical trial start-up processes.
- Project management experience in a fast-paced environment is an advantage.
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