Experience with regulatory submissions to authorities
The role involves performing assigned activities within the country to lead the start-up of investigative sites across all phases of clinical trials
Job Summary
The role involves performing assigned activities within the country to lead the start-up of investigative sites across all phases of clinical trials.
Candidates will act as a Subject Matter Expert for in-country performance, maintaining local regulatory intelligence and ensuring compliance with SOPs.
Syneos Health offers a supportive culture focused on career development, technical training, and an inclusive environment where colleagues can authentically be themselves.
Matching Summary
The role involves performing assigned activities within the country to lead the start-up of investigative sites across all phases of clinical trials.
Skills & Requirements
Must-have
Bachelor's Degree required
ICH GCP and clinical trial process knowledge
Experience with regulatory submissions to authorities
Site contract and budget negotiation skills
Trial Master File (TMF) compliance expertise
Nice-to-have
Vendor management experience in fast-paced environment
Ability to mentor junior staff and provide leadership
Strong problem-solving and communication skills
Experience with data protection guidance and local legislation