Study Start-Up Specialist: Regs, Sites & Timelines

IQVIA Holdings Inc.; United States; Remote; USD 75,000 - 110,000; Full time

Job summary

IQVIA Holdings Inc. is seeking a dedicated professional to serve as Single Point of Contact for investigative sites, SAMs, and Project Management teams across assigned studies.

Under supervision, you will ensure SOPs, WIs, and project timelines are followed, perform start-up and site activation, and manage regulatory documents and data tracking. You will support quality control and collaborate with sponsors as needed.

Qualifications

• Bachelor's degree in life sciences or related field.
• At least 3 years of clinical research experience.
• Knowledge of GCP/ICH and regulatory guidelines.
• Understanding of regulated clinical trial environment and drug development.

Responsibilities

• Serve as Single Point of Contact (SPOC) for investigators, SAM, PM team, and other departments.
• Ensure adherence to SOPs, WIs, quality of deliverables and timelines.
• Perform start up and site activation activities per regulations and instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Maintain internal systems with project-specific information.
• Review site performance metrics and provide feedback to management.
• Establish project planning and timelines; monitor progress.
• Ensure monitoring measures and contingency plans are in place.
• Communicate completion of regulatory and contractual documents.
• Track and follow up on document approvals and IP/IP release.
• Provide local expertise to SAMs and project teams during planning.
• Perform quality control of documents from sites.
• Potential direct contact with sponsors on initiatives.

Skills

GCP/ICH knowledge

Regulatory guidelines

Clinical research knowledge

Education

Bachelor's Degree in life sciences

Job description

IQVIA Holdings Inc. is seeking a dedicated professional to serve as Single Point of Contact for investigative sites, SAMs, and Project Management teams across assigned studies.

Under supervision, you will ensure SOPs, WIs, and project timelines are followed, perform start-up and site activation, and manage regulatory documents and data tracking. You will support quality control and collaborate with sponsors as needed.