# Regulatory & Start Up Specialist 1, cFSP

**Company**: IQVIA
**Location**: Mexico City
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Mexico-City-Mexico/Regulatory---Start-Up-Specialist-1---Sponsor-Dedicated_R1576112-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_838ff0a2-c93

## Description

The Regulatory & Start Up (RSU) Specialist 1 performs 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.

**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.

- 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.

- 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 team 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 Degree in life sciences (concluded).

- +1 years of clinical research experience and study start up management experience.

- Fluent English: written and oral communication skills.

- Good analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.

- Good interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.

- Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment.

## Skills

### Required
- life sciences
- clinical research
- study start up management
- English

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Mexico-City-Mexico/Regulatory---Start-Up-Specialist-1---Sponsor-Dedicated_R1576112-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)