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Fsp Sr. Regulatory And Start Up Specialist In Argentina
hace 2 semanas
The Sr.
Regulatory and Start-Up Specialist will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
May also include maintenance activities.
Developing professional individual contributor who works under moderate oversight and supervision.
Responsible for making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area.
Problems faced are general and may require understanding of broader set of issues but are not complex.
Essential Functions
• 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.
• Perform feasibility, site ID, 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 documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.
Qualifications
• Bachelor's Degree Life science or related field
• 3 years' of relevant experience working in the regulatory department in Argentina:
Local and regional committees - Initial submission, Amendments, Response to Pending Issues.ANMAT and CCIS - Initial submission (EFCA1) & ideally experience with list and calculation of medicines to be imported, Inclusion of centers (EFCA2), Amendments (EFCA3), Response to Pending Issues, IB Notification (EFCA4)ICF - Country and Site Specific CustomizationEssential Documents CollectionTMFUpdate Trackers and Check lists.
• Advanced level of English
• Ability to work independently
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