Sr Cra I Client Based Mexico
hace 7 meses
**Description**
**Clinical Research Associate II**
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**
**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
**Job responsibilities**
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assesses site processes
- Conducts Source Document Review of appropriate site source documents and medical records
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
- Verifies site compliance with electronic data capture requirements
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
- May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
- For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:
- Site support throughout the study lifecycle from site identification through close-out
- Knowledge of local requirements for real world late phase study designs
- Chart abstraction activities and data collection
- Collaboration with Sponsor affiliates, medical science liaisons and local country staff
- The SMA II may be r
-
Sr Cra
hace 6 días
Ciudad de México PPD A tiempo completo**JOB DESCRIPTION**: PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and...
-
Sr Cra
hace 7 meses
Ciudad de México Thermo Fisher Scientific A tiempo completoPPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our global...
-
Cra Ii
hace 7 meses
Ciudad de México ICON plc A tiempo completo**Experienced CRA - Mexico City, home-based role** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of...
-
Cra (Level I)
hace 7 meses
Ciudad de México Thermo Fisher Scientific A tiempo completoCRA (LeveI I) Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is...
-
Ssu & Regulatory Specialist I Client Based Mexico
hace 7 meses
Edo. de México Syneos Health Clinical A tiempo completo**Description** **Site Start-Up & Regulatory Specialist I** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer...
-
Ssu & Regulatory Specialist I Mexico Client Based
hace 7 meses
Edo. de México Syneos Health Clinical A tiempo completo**Description** **Site Start-Up & Regulatory Specialist I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value...
-
Pachuca de Soto, Hidalgo, México Sr. Muffin A tiempo completoEn Sr. Muffin, estamos comprometidos con ofrecer una excelente experiencia a nuestros clientes.Somos un equipo dinámico y apasionado por el servicio al cliente, y estamos buscando un atendente de mostrador para unirse a nuestro equipo.Como atendente de mostrador, serás responsable de:Preparar y servir bebidas y postres a nuestros clientes;Ofrecer atención...
-
Cra I/ii/senior with Experience On Site Any
hace 2 meses
México, Méx. Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **CRA any level with previous experience on-site any therapeutic area - sponsor dedicated Home Based CDMX** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market...
-
Cra I/ii/senior with Experience On Site Any
hace 4 semanas
México, Méx. Syneos Health Commercial Solutions A tiempo completo**Description** **CRA any level with previous experience on-site any therapeutic area - sponsor dedicated Home Based CDMX** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market...
-
Sr Buyer
hace 3 días
Edo. de México Reckitt A tiempo completoWant to see why procurement’s a Big Deal? As a Temporary position: SR Buyer with Reckitt, you’ll have the freedom to set the direction and lead strategic negotiations on a global basis. Objective: As Packaging Procurement Sr Buyer, you will be responsible for Blow Moulding and Injection categories for México, for all Reckitt business units, Hygiene,...
-
SAP Letra Sr
hace 12 horas
Edo. de México Softtek A tiempo completoTe invitamos a formar parte del equipo de la Practica ERP SAP: **CONSULTOR SAP LETRA SR** **Tipo de Proyecto**: Implementación de mejoras **Inglés**: No requerido **Localidad**: Cualquier localidad de México **Contrato**: Indefinido
-
Cra Line Manager
hace 2 meses
Ciudad de México, CDMX Novo Nordisk A tiempo completoCRA Line Manager **Category**:Clinical Development**Location**:Ciudad de México, Ciudad de México, MX- **Position Description** As a CRA Line Manager at Novo Nordisk, you will: - Manage a team of CRAs to ensure compliance with ICH/GCP, SOPs, and local regulations. - Oversee resource allocation and monitor staff utilization for clinical projects in the...
-
Edo. de México Syneos Health Clinical A tiempo completo**Description** Site Activation Partner (CMA ) with global experience -Home Based assigned to client Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed...
-
Sponsor Dedicated
hace 4 semanas
México, Méx. Syneos Health Commercial Solutions A tiempo completo**Description** **Clinical Research Associate II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...
-
Cra Ii
hace 1 día
Colonia Lomas de Chapultepec, México Labcorp A tiempo completoThe Clinical Research Associate II (CRA II) is responsible and accountable for site monitoring and site management. Has responsibility for clinical studies according to Company, and/or Sponsor Standard Operating Procedures, and local regulatory guidelines. Assures the implementation of project plans, as assigned. Act in the project role of a Local Project...
-
Mexico Home Based!!! Site Activation Partner Ii
hace 5 días
Edo. de México Syneos Health Clinical A tiempo completo**Description** **Site Activation Partner ( Sr CMA) with global experience -Home Based assigned to client** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed...
-
Site Monitor I
hace 3 semanas
Ciudad de México Parexel A tiempo completoParexel is looking for a SIte Monitor (CRA) in Mexico. - The Site Monitor (CRA) will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level.Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement...
-
Sma I
hace 4 meses
Ciudad de México, CDMX Icon plc A tiempo completoSMA I - Mexico, Mexico City Hybrid: Office/Remote 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 Site Management...
-
Electro-mechanical Technician I
hace 6 días
Edo. de México Bausch Health Companies A tiempo completoElectro-Mechanical Technician I (7492) **Career Opportunities: Electro-Mechanical Technician I (7492)** Requisition ID **7492** - Posted - **Mexico - Tecnofarma** - **Operations** - **MX - Tecnofarma** - City (4) **Técnico Electromecánico, Mantenimiento** - Ejecutar órdenes de trabajo de mantenimiento preventivo y correctivo a equipos e...
-
Panel Administrator
hace 7 meses
Edo. de México Ipsos A tiempo completo**General description of the role**: - Responsible for the execution and administration of all activities on online panels. **What will I be doing? **- You will work based in Mexico as part of the IIS North America team. Responsible for the execution and administration of online panels, project management with the field area. Management of delivery times,...
