IQVIA Regulatory & Start Up Specialist Role For BSc, Apply Now!

IQVIA BSc Healthcare Jobs – Apply Online For Regulatory & Start Up Specialist Role

Reg & Start Up Spec 1

Bengaluru, India

Full time

R1453970

Job Description

Job Overview:

Responsible for collaborating with the strategic CSS in the creation and distribution of various documents and system builds to drive effective and efficient study start-up activities globally.

Responsibilities:

Responsibilities include but are not limited to:

• Survey build (Key study document list): Creation of electronic survey build based off required documents needed for study.
• Package build: Prepare and build electronic packages within our system for sites, which may include essential documents, regulatory documents, etc.
• Query Tracking process: Track queries issued by regulatory bodies within our electronic system.
• Informed Consent Form (ICF) build: Create ICF template based on country requirements as received from affiliate.
• Essential Document Review: Review essential documents against checklist per country regulations.
• Completion of any other defined transactional activities: i.e., Clinical Study Report (CSR), Trial Master File Oversight.

Qualifications:

• Bachelor’s Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required.
• Competent use of Excel.
• Minimum of 1-2 years of clinical research experience and a minimum of 1+ years of study start-up experience.
• Experience with ICF review.
• Experience reviewing essential documents.
• Experience working with IRB/IEC and competent authority submissions and approvals.
• Prior experience working with Vault Clinical (or similar tracking system).

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