SR TMF ANALYST
Descripción de la oferta de empleo
Mexico Job Overview The Trial Master File (TMF) Analyst is responsible for management of sponsor TMF structure and records in the system and provides day to day operational support to the sponsor clinical trial teams on TMF structure management, TMF Quality review and inspection readiness.
Essential Functions, includes but not limited to.
• Responsible for management of expected TMF structure and records in the sponsor TMF Platform.
• Able to create sponsor TMF platform (Veeva Vault) file plan for document requirement.
• Maintenance of expected number of documents in sponsor eTMF by performing activities such as support in management of signposts, • Perform TMF quality and completeness review.
• Support inspection readiness activities as needed.
• Collaborate with the other teams/roles in sponsor organization for creating of training materials and job aids.
• Support issue resolution in collaboration with other teams, identify gaps and escalate if required to follow up and close the identified gaps and issues.
QUALIFICATION • Bachelor’s degree, preferably in a scientific discipline, is required.
• Demonstrated proficiency with TMF Management.
A minimum of 4 to 5 years of experience with eTMF system/platform • Must have strong knowledge of DIA Reference Model for TMFs, ICH GCP knowledge, regulatory requirements, and regulations.
• Strong knowledge of eTMF platforms (Veeva Vault is preferred) • Understands the reports and complexity of study life cycle milestones in Veeva Set up, EDL management, tailoring.
• Working knowledge of clinical research documents • Demonstrated current knowledge of ICH, GCP, and other regulatory guidance as applicable to management of clinical documentation • Ability to work in an extremely fast-paced environment with changing priorities • Ability to work collaboratively and cross-functionally • Attention to detail and accuracy in work • Skilled in verbal and written communication skills • Experience in Microsoft Office suite.
Competency in Microsoft Excel is added advantage.
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 https://jobs.
qvia.
om
Detalles de la oferta
- MSC Quintiles Mexico S. de R.L. de C.V.
- Sin especificar
- 29/10/2024
- 27/01/2025
Role: sr data scientistlocation: guadalajara & mexico city (remote)type of hire: full time job description: strong proficiency with r, sql,strong in python including the tensorflow, keras, and xgboost libraries... otros datos del puestorole: sr data scientistlocation: guadalajara & mexico city (remote)type......
Comrador sr ¿te gustaría pertenecer a una comercializadora de suministros industriales con más de 30 años de experiencia en el mercado y una de las más importantes del país? ¡buscamos comprador sr! funciones: identificar y gestionar el aprovisionamiento de necesidades de compra por unidad de negocio......
Descripción del empleo estamos buscando un analista de procesos sr para unirse a nuestro equipo dentro de la industria farmacéutica... el candidato ideal debe tener una sólida experiencia en análisis de procesos, para poder recopilar información de varias áreas y con ello pueda mapear y modelar procesos......
Análisis de mercado: realizar análisis de mercado y competencia para identificar tendencias y oportunidades... experiencia comprobada en la gestión de clientes y cierre de ventas importantes... gestión de clientes: mantener y fortalecer relaciones con clientes clave, asegurando su satisfacción y lealtad......
Conduct working sessions in large, global organization to gather, understand, and analyze business requirements for various functional areas, especially core hcm... ability to work creatively and analytically, prioritizing problem solving... constant desire to acquire knowledge... com/en-us/bnb_external/job/mexico/workday-hcm-functional-junior-consultant_jr-000058......
Ability to work creatively and analytically, prioritizing problem solving... this includes assisting customers in the design, implementation, scoping, estimations, support phases and other engagements... eager to try and challenge yourself... you can apply here: https://bnb... excellent internship conditions......
Conduct working sessions in large, global organization to gather, understand, and analyze business requirements for various functional areas, especially core hcm... ability to work creatively and analytically, prioritizing problem solving... constant desire to acquire knowledge... otros datos del puestoegresados......
Constant desire to acquire knowledge... we love when your pets visit us at the office! :) global perspective & people-centric approach great and dynamic work atmosphere... this role will need your skills in requirements analysis, workshop facilitation, customer management and product configuration......
Habilidades con linux, web services rest y soap, maven, jenkins, jsf, jsp... requisitos del puesto educación:estudios universitarios en el área de tecnologías de la información o carrera afín... habilidades:conocimientos avanzados en java, jse, spring (core, mvc, jdbc, etc) y hibernate......
Our employees come from various backgrounds, and we embrace the unique perspectives and talents that each individual brings to the table... excellent communication, interpersonal and consultative skills... this role will need your skills in requirements analysis, workshop facilitation, customer management......
