# Clinical Research Manager

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Salary**: $93,100.00 - $232,800.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Durham-North-Carolina-United-States-of-America/Local-Operations-Manager--Sponsor-Dedicated--Oncology-_R1564081?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_14b699b9-8c4

## 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 is meeting 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 is meeting recruitment targets with high quality data on time and within study budget

- Acting as primary Sponsor contact for assigned trial at the country level and serving as the local operational lead for complex studies

- 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 to support the study

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

- Contributing to patient understanding of protocol and patient safety by preparing country-specific informed consent documents

- 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
- clinical trials management
- regulatory compliance
- vendor management
- trial monitoring
- data quality management

### Nice to have
- oncology
- trial management
- site selection
- recruitment strategies

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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/Local-Operations-Manager--Sponsor-Dedicated--Oncology-_R1564081?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)