[Hiring] Site Activation Specialist 1 @Syneos Health

Role Description

This role will be managing Investigator Initiation Package/ Investigational Product Release Form/ Activation Greenlight Form to approval, following Sponsor indication and quality procedures. The package will include regulatory documents such as:

• CVs
• FDF
• FDA 1572
• GCP trainings

The SAS will pre-fill and distribute essential documents to sites, review/QC completed documents for consistency, and assemble the whole pack (up to 40 docs/site at start-up) for approval so that the site can receive the study-drug and start screening.

• Leading and collaborating on local and central Institutional Research Board (IRB) / Institutional Ethics Committee / Central Ethics Committee activities for countries in scope, including answering queries from such authorities.
• Managing protocol amendments and essential document updates throughout the lifecycle of the study.
• Site interaction and working with sites and site personnel to complete study documents at the expected quality.

Qualifications

• Experience in managing regulatory documents.
• Strong understanding of IRB and ethics committee processes.
• Excellent communication skills.
• Ability to work collaboratively with site personnel.

Requirements

• Proven experience in clinical trial management.
• Knowledge of GCP and regulatory requirements.
• Detail-oriented with strong organizational skills.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Inclusive culture where you can authentically be yourself.