# Site Activation Specialist (FSO)

**Company**: Syneos Health
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/JPN-Tokyo-Hybrid/Site-Activation-Specialist--FSO-_25105544-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_97a90a93-c0f

## Description

Syneos Health is seeking a Site Activation Specialist (FSO) to join their team. The successful candidate will perform assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. The role involves delivery, with moderate oversight from the Line Manager and specialist knowledge in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, collection and review of essential documents required for site initiation and site activation activities.

Responsibilities:

- Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules, with moderate oversight from the SSU Country Manager.

- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.

- Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.

- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

- Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned.

- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Requirements:

- Bachelor’s Degree.

- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.

- Ability to understand clinical protocols and associated study specifications.

- Detailed understanding of clinical trial start-up processes.

- Ability to manage external vendors to contract effectively.

- Strong organizational skills with ability to handle multiple tasks effectively.

- Strong written and verbal communication and interpersonal skills.

- Ability to manage multiple project budgets with increased complexity and value.

- Quality-driven in all managed activities.

- Good negotiating skills.

- Good problem-solving skills.

- Demonstrated ability to work independently as well as part of a team.

## Skills

### Required
- clinical trials
- GCP
- regulatory submissions
- contract management
- budget management
- communication
- problem-solving

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/JPN-Tokyo-Hybrid/Site-Activation-Specialist--FSO-_25105544-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)