Regulatory and Start Up Specialist (FSP) at IQVIA

Job Overview:

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Perform admissions of regulatory documents.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Perform quality control of documents provided by sites.
• Inform team members of completion of regulatory and contractual documents for individual sites.

Requirements:

• Bachelor’s Degree in life sciences or a related field
• 3 years clinical research experience, including 1 year experience in a leadership capacity or equivalent combination of education, training, and experience.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.