FSP - Sr. Regulatory and Start Up Specialist
hace 6 días
FSP - Sr. Regulatory and Start Up Specialist Job Overview 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. Responsibilities 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 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 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 regulatory and contractual documents for individual sites. 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. 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 in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience. 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience. In-depth knowledge of clinical systems, procedures, and corporate standards. Good negotiating and communication skills with ability to challenge, if applicable. Effective communication, organizational, and interpersonal skills. Ability to work independently and to effectively prioritize tasks. Ability to manage multiple projects. 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. Ability to establish and maintain effective working relationships with coworkers, managers and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at Seniority level: Mid-Senior level Employment type: Full-time Job function: Legal Industries: Hospitals and Health Care #J-18808-Ljbffr
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Senior Study Start-up
hace 3 semanas
Municipio de Rincón de los Sauces, Argentina Emmes Group A tiempo completoA leading clinical research organization is seeking a Study Start-up Associate Senior in Rincón de los Sauces, Argentina. This role is vital for coordinating regulatory submissions and ensuring compliance with local and global requirements in clinical trials. Ideal candidates will have over 6 years of experience in regulatory affairs across multiple...
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Study Start-up Associate Senior
hace 3 semanas
Municipio de Rincón de los Sauces, Argentina Emmes Group A tiempo completoOverview Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Founded more than 47 years ago as Emmes, we entered the US government leading clinical research arena before expanding into public‑private partnerships and commercial biopharma. Our leading capabilities cover...
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Study Start Up Manager
hace 4 semanas
Rincón de los Sauces, Argentina Medpace A tiempo completoOverview Our LATAM clinical trial activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team in Buenos Aires! This position plays a key role in the study start up process at Medpace. Responsibilities Efficiently manage and successfully execute all aspects of global...
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FSP - Sr. Contract Negotiator in Argentina or Mexico
hace 2 semanas
Municipio de Esquel, Argentina IQVIA A tiempo completoFSP - Sr. Contract Negotiator in Argentina or Mexico Develop the global contracting strategy and support the delivery of all required start‑up contracting activities for selected sponsors, studies or multi‑protocol programs as determined by the Sponsor’s requirements. Essential Functions Develop coordinate the development of investigator grants and...
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Site Readiness and Regulatory Specialist I
hace 3 días
Municipio de Esquel, Argentina Fortrea A tiempo completoSite Readiness and Regulatory Specialist I Job Overview Primary contact with investigative sites during study maintenance and, when assigned, site startup activities, responsible for collecting required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the agreed timelines with...
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Municipio de Esquel, Argentina IQVIA A tiempo completoA leading global provider of clinical research services is seeking a Senior Regulatory and Start Up Specialist in Chubut, Argentina. The role entails performing site activation activities in compliance with local and international regulations, overseeing project timelines, and ensuring quality control of documents. Candidates must hold a Bachelor's degree in...
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Regulatory Labeling Manager
hace 3 semanas
Municipio de Esquel, Argentina Syneos Health A tiempo completoRegulatory Labeling Manager (NA and LATAM Only) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...
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Sr Pharmacovigilance Specialist
hace 4 semanas
Municipio de Rincón de los Sauces, Argentina IQVIA A tiempo completoSr Pharmacovigilance Specialist (Operations Specialist 2) Join to apply for the Sr Pharmacovigilance Specialist (Operations Specialist 2) role at IQVIA. This is a full-time, regular, 100% home-based role. Job Overview Apply knowledge and expertise, including complex decision making activities, to review, assess and process safety data and information across...
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Municipio de Esquel, Argentina Syneos Health A tiempo completoRegulatory Publishing Specialist - Veeva Experience Required Join to apply for the Regulatory Publishing Specialist - Veeva Experience Required role at Syneos Health. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Our Clinical Development model brings the customer and the patient...
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Hybrid Regulatory Affairs Specialist – Argentina
hace 1 semana
Municipio de Rincón de los Sauces, Argentina Medtronic A tiempo completoA leading global healthcare technology company is seeking a Regulatory Affairs Specialist in Argentina to manage regulatory submissions, ensure compliance, and liaise with regulatory agencies. The role requires a Bachelor's degree and a minimum of 2 years of experience in the medical devices or pharmaceutical industry. The candidate must be fluent in English...
