FSP - Sr. Regulatory and Start Up Specialist
hace 4 semanas
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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Study Start Up Manager
hace 2 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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Site Readiness and Regulatory Specialist I
hace 3 semanas
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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Regulatory & Site Activation Lead - Clinical Trials
hace 4 semanas
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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Business Start-Up Analyst
hace 1 semana
Municipio de Esquel, Argentina GBS Group A tiempo completoGBS Group Buenos Aires, Buenos Aires Province, Argentina Location: Remote - Anywhere in LATAM Job Type: Full‑Time - Contractor Compensation: USD 1600‑1800/ Monthly Language requirement: Advanced level of English & Spanish About The Role Are you ready to play a pivotal role in helping entrepreneurs launch and grow their businesses in the USA? As a...
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Regulatory Publishing Specialist- Veeva Experience Required
hace 3 semanas
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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Mgr, FSP 360
hace 7 días
Municipio de Esquel, Argentina Syneos Health A tiempo completoSenior Manager, FSP 360 – a role focused on leading a multifunctional team within Syneos Health’s Functional Service Provider 360 model. The position focuses on customer delivery, business impact, and people leadership in a full‑service environment. Job Responsibilities Customer Delivery and Success Develop and foster strong, collaborative...
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Senior Manager FSP 360 Delivery
hace 7 días
Municipio de Esquel, Argentina Syneos Health A tiempo completoA global biopharmaceutical solutions organization is seeking a Senior Manager for its FSP 360 model in Argentina. This mid-senior level position emphasizes customer delivery, impactful business outcomes, and people leadership within a full-service framework. The role involves fostering relationships with clients, ensuring compliance, managing team...
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Hybrid Regulatory Affairs Specialist – Argentina
hace 4 semanas
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...
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Regulatory Affairs Specialist
hace 4 semanas
Municipio de Rincón de los Sauces, Argentina Medtronic A tiempo completoRegulatory Affairs Specialist /Argentina At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life We’re a mission-driven leader in medical technology...
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Sr Biostatistician
hace 4 semanas
Municipio de Esquel, Argentina Syneos Health A tiempo completoSr Biostatistician – Neurology (Europe and LATAM only) Apply with English‑language CVs. The role is open to Europe (excluding Switzerland) or LATAM (ARG, BRA, COL, MEX). Job Responsibilities Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics...
