Clinical Process Coordinator

hace 5 días

Ciudad de México, 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 local regulations to best meet customer needs while working toward organizational goals and strategies.

Provides project-related support to the project management teams of assigned clinical research studies. Establishes and maintains all project documentation; conducts technical reviews and audits of files for accuracy and completion; tracks key communications and documents; and maintains internal systems and databases.

Essential Functions:

Includes but not limited to:

  • Support in ensuring compliance with contract, SOPs, GCPs, policies, and regulatory
  • Support in meeting quality & timeline metrics
  • Assist study manager/ study lead in effective management of eTMF and its Inspection Readiness
  • Establishment and maintenance of Study in Gilead's Global Clinical Trials Management System (GILDA)
  • Weekly reports and updates, dashboard management
  • Tracking the subject, site and visit status and milestones in CTMS/sCTMS.
  • Assist the Study Lead in preparing reports and trackers to track various metrics (electronic data capture report, action items, Protocol deviations etc)
  • Perform access management for the study team
  • Support the clinical project team by accurately updating and maintaining clinical systems within project timelines.

The CPC works in partnership with the Study Lead and the Study Process lead (CL) providing support with project management activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project/s.

Qualifications

  • Bachelor's Degree Life sciences or other related field Req
  • Knowledge of clinical trials - knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP), relevant local laws, regulations, and guidelines, towards clinical trial conduct.
  • Typically requires 0 - 2 years of prior relevant experience.
  • 1 year of relevant clinical research experience with analytical/financial skills or relevant Project Management experience or equivalent combination of education, training, and experience.
  • GCP Course will be highly valued
  • Advanced English level
  • Excellent Communication and interpersonal skills.
  • Excellent Problem solving and Organization skills
  • Attention to detail skills.

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

  • Clinical Team Lead

    hace 2 semanas

    Ciudad de México, Ciudad de México Fortrea A tiempo completo

    Clinical Team Lead, Phase IAre you passionate clinical research professional ready to lead the charge in groundbreaking trials? Join Fortrea as a Phase I Clinical Team Lead (CTL) and drive clinical project excellenceAbout the RoleAs a Phase I Clinical Team Lead, you'll own the clinical delivery process, ensuring successful trial delivery in collaboration...

  • Clinical Team Lead

    hace 2 semanas

    Ciudad de México, Ciudad de México Fortrea A tiempo completo

    Clinical Team Lead, Phase IAre you passionate clinical research professional ready to lead the charge in groundbreaking trials? Join Fortrea as a Phase I Clinical Team Lead (CTL) and drive clinical project excellenceAbout The RoleAs a Phase I Clinical Team Lead, you'll own the clinical delivery process, ensuring successful trial delivery in collaboration...

  • Clinical Lead

    hace 2 semanas

    Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Job OverviewThe Clinical Lead provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project's overall objectives to the Sponsor's satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our SOPs, policies...

  • Clinical Trials Bookkeeper

    hace 2 semanas

    Ciudad de México, Ciudad de México Angel City VA A tiempo completo

    Clinical Trials Bookkeeper.Job Description:Key Responsibilities:« Track all outstanding receivables related to clinical trials, including sponsorpayments, and reimbursements. QC patients visits; prepare and issue invoices in accordance with contractmilestones and payment schedules.« Follow up regularly with sponsors, CROs, to ensure timely payment.«...

  • Manager, Clinical Operations

    hace 6 días

    Ciudad de México, Ciudad de México ICON plc A tiempo completo

    Home Based - MexicoICON 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 Manager, Clinical Operations to join our diverse and...

  • Manager, Clinical Operations

    hace 6 días

    Ciudad de México, Ciudad de México ICON Strategic Solutions A tiempo completo

    People Lead Exp. - Home Based - MexicoICON 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 Manager, Clinical Operations to join...

  • Manager, Clinical Operations

    hace 2 semanas

    Ciudad de México, Ciudad de México ICON plc A tiempo completo

    CDMXICON 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 Manager, Clinical Operations to join our diverse and dynamic team. As a...

  • Clinical Trial Material

    hace 2 semanas

    Ciudad de México, Ciudad de México ICON plc A tiempo completo

    Home Based - MexicoICON 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 Senior Manager, Clinical Supplies Management to join our...

  • Manager, Clinical Supplies

    hace 5 días

    Ciudad de México, Ciudad de México IRE A tiempo completo

    Mexico. Home based.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 developmentWe are currently seeking a Manager, Clinical Supplies to join our diverse and...

  • Experienced Clinical Programmer

    hace 2 semanas

    Ciudad de México, Ciudad de México Johnson & Johnson Innovative Medicine A tiempo completo

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...