FSP - Sr. Regulatory and Start Up Specialist
Job Title: FSP - Sr. Regulatory and Start Up Specialist
Job Location: Buenos Aires, Argentina
Job Location Type: Home-based
Job Contract Type: Full time
Job Seniority Level:
reputed companyJob reputed company The Sr. Regulatory & Start Up Specialist will reputed company tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, reputed company operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
Essential Functions • Under general supervision, serve as Single reputed company of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to reputed company operating procedures (SOPs), Work Instructions (WIs), reputed company of designated deliverables and project timelines. • reputed company start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. • Prepare site regulatory documents, reviewing for completeness and accuracy. • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. • Review and reputed company feedback to management on site performance metrics. • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in reputed company and implement contingency plan as needed. • Inform team members of completion of regulatory and contractual documents for individual sites. • Review, reputed company and follow up the reputed company, the approval and execution of documents, regulatory, ethics, Informed Consent reputed company (reputed company), and Investigator Pack (IP) release documents, in line with project timelines. • reputed company local expertise to SAMs and project team during initial and on-reputed company project reputed company planning. • reputed company reputed company control of documents provided by sites. • May have reputed company contact with sponsors on specific initiatives.
Qualifications
• Bachelor's Degree in life sciences.
• +3 years of clinical research experience reputed company regulatory area in Argentina:
Local submissions
reputed company customization
Presentations to ethics committee & ANMAT.
• Fluent English: written and oral communication skills
• Ability to work independently
reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com
reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.
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Originally posted on Himalayas
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