Centralized Monitor, Dutch Speaking at IQVIA

JOB DESCRIPTION

Centralized Monitor - Dutch Speaking

Are you:

• Someone who understands dynamics of working with the sites?
• Results driven and detail-oriented?
• Good at supporting others on problem solving?
• Good at planning, time management and prioritization?
• Skilled at software and computer use, that enjoys technology applied to data analysis?
• Understands clinical trial conduct, and skill in applying applicable clinical research regulatory requirements and relevant local laws, regulations and guidelines?
• Able to communicate efficiently and work well across cultures and geographies?
• Can you speak, read and write Dutch?

What is a Centralized Monitor?

A Centralized Monitor (CM) is a key skilled and clinically experienced team member of IQVIA Centralized Monitoring Department. A CM provides remote project support and assistance across multiple projects, sites and teams and reviews the structured clinical data output with access to medical charts.

What are the responsibilities of a CM?   

As a CM, you will:

• Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.                          
• Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.
• May perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).
• May assist in Developing required basic data analytics scope and performing the trend analytics for their respective study(ies).
• May participate in (study) team meetings and interaction with cross functional staff to verify information and/or triage new data issues or prior identified action items
• Escalate quality issues pertaining to site to respective Centralized Monitoring Lead / Sr. Centralized Monitor.
• May perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy.
• Review any other information as necessary to determine overall readiness of the patient information for next level review.
• Interaction with sites/CRA and follow-up on study required milestones from the project start until close out.

Do you need experience or a degree to apply for this position?

• You must have a Bachelor's degree in life sciences or related field
• At least 1 year experience in clinical research field preferred.
• Fluency in Afrikaans and English is essential.