Description
Syneos Health is seeking a Sponsor Dedicated Site Activation Specialist I to join their team in Sofia. The successful candidate will be dedicated to one single client and will require attendance at client offices based in Sofia.
The role involves performing assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. The Specialist will be responsible for the delivery of site activation activities, including ethics and regulatory submissions, collection and review of essential documents required for site initiation and site activation activities.
Key responsibilities include:
- Coordinating site start-up and activation activities to ensure studies are initiated on time and to quality standards
- Managing regulatory, ethics, and essential document submissions while ensuring compliance with applicable requirements
- Collaborating with cross-functional teams to resolve issues, mitigate risks, and support timely site activation
- Overseeing site activation milestones, including supply management, IP release, and site readiness approvals/greenlights
- Tracking progress, maintaining study metrics and databases, providing status updates, and supporting audit readiness and process improvements
The ideal candidate will have:
- A Bachelor's Degree in a healthcare or scientific field
- A minimum of 1-2 years of clinical research experience and preferably 1+ years of study start-up management experience for the designated region
- EUCTR/CTIS experience will be a plus
- Good understanding of clinical trial process across Phases II-IV and ICH GCP
- Ability to interact effectively and appropriately with investigative site personnel
- Good organizational skills and attention to detail, with proven ability to handle multiple tasks effectively
- Ability to take direction from multiple individuals and set priorities accordingly
- Strong computer skills, including Word, Excel, PowerPoint, Publisher