# Regulatory & Start Up Specialist 1, cFSP - Global Support

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

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Mexico-City-Mexico/RSU-Specialist-I--FSP-Sponsor-Dedicated_R1567362?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ad474b80-3ac

## Description

The Regulatory & Start Up Specialist 1, cFSP - Global Support role involves proactively driving and executing start-up and maintenance-related activities and deliverables for assigned studies and sites in Mexico.

**Key Responsibilities:**

- Serve as Single Point of Contact (SPOC) 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

- 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

- 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 on the progress, approval, and execution of documents

- Provide local expertise to SAMs and project teams during initial and ongoing project timeline planning

- Perform quality control of documents provided by sites

- May have direct contact with sponsors on specific initiatives

**Requirements:**

- Bachelor's degree in life sciences

- At least 1 year of clinical research experience and study start-up management experience

- Fluent English: written and oral communication skills

- Good analytical and critical thinking skills

- 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/RSU-Specialist-I--FSP-Sponsor-Dedicated_R1567362?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)