Reg & Start Up Spec 2

7 days ago

Bengaluru Karnataka, India IQVIA Full time

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 3- 6years of clinical research experience and a minimum of 3+ 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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