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 field3 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.