# Site Activation Specialist

**Company**: IQVIA
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/London-United-Kingdom/Study-Start-Up-Specialist---UK-IQVIA-Biotech_R1571744?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_a969b5de-13f

## Description

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. This is a Home Based opportunity requiring in-depth knowledge of UK clinical trial landscape and submissions.

**Essential Functions**

- Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary under general supervision.

- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.

- Perform start-up and site activation activities according to applicable regulations, SOPs and work instructions.

- Distribute completed documents to sites and internal project team members.

- Prepare site regulatory documents, reviewing for completeness and accuracy.

- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project-specific information.

- Review and provide feedback to management on site performance metrics.

- Review, establish and agree on project planning and project timelines.

- Ensure monitoring measures are in place and implement contingency plans as needed.

- Inform team members of completion of regulatory and contractual documents for individual sites.

- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.

- Provide local expertise to SAMs and project teams during initial and on-going project timeline planning.

- Perform quality control of documents provided by sites.

- May have direct contact with sponsors on specific initiatives.

**Qualifications**

- Bachelor’s Degree in life sciences or a related field.

- 3 years of clinical research experience.

- In-depth knowledge of clinical systems, procedures, and corporate standards.

- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

- Understanding of regulated clinical trial environment and knowledge of drug development process.

## Skills

### Required
- GCP/ICH
- clinical research
- regulatory guidelines
- standard operating procedures

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/London-United-Kingdom/Study-Start-Up-Specialist---UK-IQVIA-Biotech_R1571744?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)