Senior Study Start up Specialist, IQVIA Biotech

hace 3 días

Municipio de General Roca, Argentina IQVIA A tiempo completo

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. #J-18808-Ljbffr

  • Senior Study Start up Specialist, IQVIA Biotech

    hace 2 días

    Municipio de Resistencia, Argentina SAP A tiempo completo

    Senior Study Start up Specialist, IQVIA Biotech IQVIA 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....

  • Senior Study Start up Specialist, IQVIA Biotech

    hace 3 días

    Municipio de Viedma, Argentina Trafilea A tiempo completo

    Senior Study Start up Specialist, IQVIA Biotech IQVIA whatjobs.com Overview 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...

  • Senior Study Start up Specialist, IQVIA Biotech

    hace 3 días

    Ciudad de Mendoza, Argentina Midorick Solutions A tiempo completo

    Senior Study Start up Specialist, IQVIA Biotech IQVIA 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....

  • Senior Study Start up Specialist, IQVIA Biotech

    hace 3 días

    Ciudad de Mendoza, Argentina IQVIA A tiempo completo

    Overview Job OverviewPerform 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...

  • Senior Study Start up Specialist, IQVIA Biotech

    hace 2 días

    Municipio de Río Gallegos, Argentina goFLUENT A tiempo completo

    Overview 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,...

  • Senior Clinical Study Start-Up Lead

    hace 3 días

    Municipio de Río Gallegos, Argentina DEPT A tiempo completo

    A global leader in clinical research services is seeking a Senior Study Start-up Specialist based in Río Gallegos, Santa Cruz, Argentina. This role involves performing site activation activities, ensuring adherence to regulations, and managing project timelines. Candidates should have a Bachelor's Degree in life sciences and at least 3 years of clinical...

  • Principal Biostatistician

    hace 2 semanas

    Municipio de Esquel, Argentina IQVIA A tiempo completo

    Principal Biostatistician Company: IQVIA Location: Mexico, Argentina or Brazil (Remote – must be available to work Eastern or Central U.S. time zones) We are seeking an experienced Principal Statistician to join our BIOS team for one of our FSP clients. This advanced-level position requires strong expertise in biostatistics and programming, with a focus on...

  • Senior Study Startup Lead — Site Activation

    hace 2 días

    Municipio de Resistencia, Argentina SAP A tiempo completo

    A global provider of clinical research services is seeking a Senior Study Start up Specialist in Chaco, Argentina. The role involves performing site activation activities, ensuring compliance with regulations, and serving as the primary contact for investigative sites. Candidates should have a Bachelor's degree in life sciences and 3 years of clinical...

  • Senior Site Activation

    hace 3 días

    Municipio de General Roca, Argentina IQVIA A tiempo completo

    A global healthcare company is seeking a professional to perform Site Activation activities in Río Negro, Argentina. The ideal candidate will ensure adherence to regulations and SOPs while serving as a Single Point of Contact for teams involved in clinical studies. Responsibilities include preparing regulatory documents, overseeing project timelines, and...

  • Study Start Up CRA

    hace 3 semanas

    Municipio de Rincón de los Sauces, Argentina ICON Strategic Solutions A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and...