Senior Study Start Up Specialist

hace 3 semanas

Xico, México Iqvia A tiempo completo

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.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 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 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 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.

  • Senior Study Start Up Associate

    hace 3 semanas

    Xico, México Icon Plc A tiempo completo

    Job Advert Posting- At ICON, it's our people that set us apart.Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.- ICON plc is a world-leading healthcare intelligence and clinical research organization.From molecule to medicine, we advance clinical research by...

  • Study Start Up Associate Ii

    hace 3 semanas

    Xico, México Icon Plc A tiempo completo

    Study Start Up Associate II - Mexico - HomebasedICON 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 developmentWe are currently seeking a Study Start Up Associate II...

  • Study Start Up Manager

    hace 3 semanas

    Xico, México Medpace, Inc. A tiempo completo

    Job Summary: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 Mexico City!This position plays a key role in the study start up process at Medpace.If you want an exciting career where you use your previous expertise and can...

  • Study Start Up Associate I

    hace 3 semanas

    Xico, México Icon Plc A tiempo completo

    At ICON, it's our people that set us apart.Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.ICON plc is a world-leading healthcare intelligence and clinical research organization.From molecule to medicine, we advance clinical research by providing outsourced...

  • Study Start Up Associate I

    hace 3 semanas

    Xico, México Icon A tiempo completo

    At ICON, it's our people that set us apart.Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...

  • Senior Centralized Study Specialist

    hace 3 semanas

    Xico, México Mex Fortrea Clinical Development Mexico A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.With over 19,000 staff...

  • Study Start Up Specialist I

    hace 3 semanas

    Xico, México Iqvia A tiempo completo

    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.Essential Functions- Under general supervision, serve as...

  • Senior Centralized Study Specialist: Clinical Systems Lead

    hace 3 semanas

    Xico, México Mex Fortrea Clinical Development Mexico A tiempo completo

    A global clinical research organization in Mexico City is looking for a Senior Centralized Study Specialist to manage clinical systems, support study documentation, and ensure compliance.This role involves mentoring junior team members and contributing to the execution of clinical trials.Ideal candidates have 4-5 years of clinical research experience and a...

  • Clinical Trial Start-Up Associate I

    hace 3 semanas

    Xico, México Icon A tiempo completo

    A global healthcare research organization is seeking a Study Start Up Associate I in Mexico City.The position involves facilitating clinical trial initiation, ensuring compliance and managing site communications.Ideal candidates will hold a Bachelor's degree in life sciences and possess strong organizational, communication, and multitasking abilities.The...

  • Study Start Up Associate Ii

    hace 2 semanas

    Xico, México Icon Plc A tiempo completo

    Study Start Up Associate II (Site Activation Associate) - Mexico - HomebasedICON 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 developmentAt ICON, it's our people...