Study Process Lead

hace 4 semanas

Ciudad de México IQVIA A tiempo completo

Job OverviewLeads and oversees the execution of clinical projects and research studies in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies.Essential Functions:- Registration on clinicaltrials.gov- TMF Management Plan- Perform Functional checks and eTMF maintenance for study- Activate sites in GILDA- Preparing, handling, distributing, filing, and archiving of clinical documentation and reports as per the scope of work and standard operating procedures.- Assist the Study lead in providing a periodic review of the prospective principal investigators to be selected for participation in the study.- To ensure that the CRA transition documentation is complete.- Assist with periodic review of study files for accuracy and completeness.- Perform close out activities for study in close out phase. Perform administrative tasks to support team members with clinical trial execution as needed.- Assist the Quality Team with Monthly Investigator Quality reviews, mitigation strategy calls and preparation of Meeting minuteThe **Study Process Lead** is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.Study Process Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times.**Qualifications**:- Bachelor's Degree Life sciences or related field Req- 3-5 years of relevant experience.- Advanced English level- Strong written and verbal communication skills- Results and detail-oriented approach to work delivery and output- Good problem solving, time management and prioritization skills- Proven ability to work on multiple projects balancing competing priorities- Good leadership skills- Ability to work across cultures and geographies with a high awareness and understanding of cultural differences

  • Study Process Lead

    hace 4 semanas

    Ciudad de México IQVIA A tiempo completo

    **Location: Mexico City, Mexico****Hybrid role**Job OverviewLeads and oversees the execution of clinical projects and research studies in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies.Essential Functions:- Registration on clinicaltrials.gov- Activate sites in GILDA-...

  • Country Study Operations Manager

    hace 1 semana

    Ciudad de México Parexel A tiempo completo

    **Parexel FSP**is hiring multiple **Country** **Study Operations Managers** **(cSOMs)**in **Brazil, Chile and Mexico**. The **Country** **Study Operations Managers** **(cSOM)** will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close. The Study Operations Manager has...

  • Centralized Study Specialist

    hace 5 días

    Ciudad de México Fortrea 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. Conducting operations in...

  • Clinical Process Coordinator

    hace 4 semanas

    Ciudad de México IQVIA A tiempo completo

    **Clinical Process Coordinator, cFSP****Hybrid role (Mexico City)**Job OverviewLeads and oversees the execution of clinical projects and research studiesProvide project related assistance for all assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, in accordance with global and local...

  • Director's Assistant

    hace 3 días

    Ciudad de México Kingswood Study Camps Canada A tiempo completo

    **About Us**:Kingswood Study Camps Canada is a renowned organization dedicated to providing exceptional educational language camps across Canada. With a focus on immersive learning experiences, we empower students to excel academically while fostering cultural understanding and personal growth.**Position Overview**:We are seeking a dynamic and organized...

  • Director's Assistant

    hace 3 días

    Ciudad de México Kingswood Study Camps Canada A tiempo completo

    **About Us**: Kingswood Study Camps Canada is a renowned organization dedicated to providing exceptional educational language camps across Canada. With a focus on immersive learning experiences, we empower students to excel academically while fostering cultural understanding and personal growth. **Position Overview**: We are seeking a dynamic and organized...

  • Clinical Process Coordinator

    hace 2 días

    Ciudad de México IQVIA A tiempo completo

    **Clinical Process Coordinator, cFSP** **Hybrid role (Mexico City)** Job Overview Leads and oversees the execution of clinical projects and research studies Provide project related assistance for all assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, in accordance with global and...

  • Centralized Study Specialist

    hace 6 días

    Ciudad de México, CDMX Fortrea 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. Conducting operations in...

  • Clinical Study Planning Manager/project Manager

    hace 3 semanas

    Ciudad de México Parexel A tiempo completo

    **Responsibilities**:- Lead the development of realistic study timelines, from design through final study reporting on priority programs- Maintaining accuracy of clinical study timeline information in Company data control systems (e.g., Planisware (PPM)- Tracking, documenting, and ensuring key stakeholder involvement and timely delivery of clinical study...

  • Study Support Assistant

    hace 2 semanas

    Ciudad de México ICON 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.**What you will be doing**:- Recognize, exemplify and adhere to ICON's values, which center on our...