# Clinical Research Manager

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Salary**: $68,400.00 - $232,800.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Durham-North-Carolina-United-States-of-America/Senior-Clinical-Trial-Manager--Oncology--Sponsor-Dedicated-_R1572242?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_c4b12e4a-c2f

## Description

We are seeking a Clinical Research Manager to serve as a subject matter expert and resource for quality and compliance standards across assigned studies.

The successful candidate will lead and contribute to quality Site Selection, ensure local/country team meets recruitment targets with high-quality data on time and within study budget, and act as primary Sponsor contact for assigned trial at the country level.

Key responsibilities include:

- Leading and contributing to quality Site Selection through participation in site feasibility and site qualification visits

- Ensuring local/country team meets recruitment targets with high-quality data on time and within study budget

- Acting as primary Sponsor contact for assigned trial at the country level

- Driving study compliance by maintaining and updating trial management systems and analyzing trial progress

- Leading development and execution of country-level recruitment strategies and contingency planning

- Delivering advanced vendor management at the country level

- Ensuring high standards for study monitoring and facilitating Site Manager training when needed

- Contributing to patient understanding of protocol and patient safety

- Ensuring trial subject safety and reporting adverse events within required timelines

- Ensuring Inspection Readiness by maintaining complete, accurate, and timely data and essential documents

- Providing oversight and guidance to improve site data quality and operational performance

- Keeping oneself inspection ready and knowledgeable for current work

- Working closely with Site Managers to ensure CAPAs are implemented for audits/inspections or any quality-related visits

- Ensuring accurate finance reporting and trial delivery within budget

- Keeping the trial in compliance with local regulatory requirements

- Serving as a trainer, mentor, and subject matter expert for systems/processes and local trial management practices

Requirements:

- BA/BS degree in a health or science-related field

- 3 to 5+ years of trial management experience, including experience independently managing complex clinical trials and leading country-level trial execution activities

- Oncology experience

- Strong working knowledge of ICH-GCP, Sponsor SOPs, local laws and regulations, assigned protocols, and associated protocol-specific procedures

- Strong IT skills in appropriate software and Sponsor systems

- Willingness to travel with occasional overnight stay away from home according to business needs

- Proficient in speaking and writing the country language and English

## Skills

### Required
- ICH-GCP
- Sponsor SOPs
- clinical trials management
- oncology
- regulatory compliance

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Durham-North-Carolina-United-States-of-America/Senior-Clinical-Trial-Manager--Oncology--Sponsor-Dedicated-_R1572242?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)
