Site Start-Up
hace 7 días
About the Role
Syneos Health Clinical is seeking a highly skilled Site Start-Up & Regulatory Specialist I to join our team in Mexico. As a key member of our team, you will be responsible for providing quality on deliverables at the country level and following project requirements and applicable country rules.
Key Responsibilities
- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
- Monitors basic financial aspects of the project and the number of hours/tasks available per contract.
- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner.
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Qualifications
- Associate's Degree or equivalent combination of education and training.
- Good understanding of clinical trial process across Phases II-IV and ICH GCP.
- Ability to interact effectively and appropriately with investigative site personnel.
Why Syneos Health Clinical
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.
-
Operations and Start-Up Leader
hace 2 semanas
Ecatepec de Morelos, México Nestle Operational Services Worldwide Sa A tiempo completo**Job Purpose:**As a CAPEX project team member, you will play a crucial role in ensuring vertical start-up and sustained performance by properly preparing and leading the start-up phase.**Key Responsibilities:**Assist in the development of User Requirement Specifications during the project design phase by identifying local site operational...
-
Ecatepec de Morelos, México Nestle Operational Services Worldwide Sa A tiempo completoLocation: MexicoNumber of positions: 2**Position purpose**: As a CAPEX project team member, ensure vertical start-up and sustained performance by properly preparing and leading the start-up phase.**Required knowledge and experience**:Bachelor's degree in engineering or related fieldsAdvanced intermediate level of English2 to 3 years of successful production...
-
Site Start-Up
hace 1 semana
Ecatepec de Morelos, México Syneos Health Clinical A tiempo completoAbout the RoleSyneos Health Clinical is seeking a highly skilled Site Start-Up & Regulatory Specialist I to join our team in Mexico. As a key member of our start-up team, you will be responsible for providing quality on deliverables at the country level and following project requirements and applicable country rules.Key ResponsibilitiesWorks within the...
-
Study Start Up Associate II
hace 2 semanas
Ciudad de México, Ciudad de México Icon A tiempo completoJob SummaryThe Study Start Up Associate II will be responsible for collecting, preparing, reviewing, approving, processing, and tracking regulatory and site-level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines, and the principles of ICH/GCP.This role will also...
-
Study Start Up Associate II
hace 2 semanas
Ciudad de México, Ciudad de México Icon A tiempo completoJob SummaryWe are seeking a highly skilled Study Start Up Associate II to join our team at ICON. As a key member of our team, you will be responsible for collecting, preparing, reviewing, approving, processing, and tracking regulatory and site-level critical documents required for study site activation.Key ResponsibilitiesCollect, prepare, review, approve,...
-
Regulatory and Start-Up Specialist
hace 2 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob OverviewWe are seeking a highly skilled Regulatory and Start-Up Specialist to join our team at IQVIA. As a key member of our FSP team, you will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs),...
-
Study Start Up Associate II
hace 3 semanas
Ciudad de México, Ciudad de México Icon Plc A tiempo completoAbout ICONAt ICON, we pride ourselves on being a world-leading healthcare intelligence and clinical research organization. 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.We advance clinical research by providing outsourced services to pharmaceutical,...
-
FSP Regulatory and Start-Up Specialist
hace 2 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob Title: FSP Regulatory and Start-Up SpecialistJob Overview:We are seeking a highly skilled Regulatory and Start-Up Specialist to join our FSP team in a Home Based role. As a key member of our team, you will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or...
-
Regulatory and Start-Up Specialist 2, cFSP
hace 2 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoSite Management Specialist, Regulatory and Start-UpLocation: RemoteJob OverviewThis position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members. This includes supporting site qualification, site level regulatory green light and...
-
Regulatory Specialist
hace 1 mes
Ciudad de México, Ciudad de México IQVIA A tiempo completoRegulatory and Start Up SpecialistWe are seeking a highly skilled Regulatory and Start Up Specialist to join our team in Mexico. As a key member of our FSP team, you will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard...
-
Clinical Development Manager
hace 4 días
Ecatepec de Morelos, México Syneos Health Clinical A tiempo completoAbout UsSyneos Health Clinical is a leading biopharmaceutical solutions organization that accelerates customer success.We are a fully integrated company purpose-built to provide high-value insights that speed therapies to patients.Our ApproachWe lead with a product development mindset, seamlessly connecting our capabilities to simplify and streamline our...
-
Site Security Specialist
hace 4 semanas
Ecatepec de Morelos, México Mondelēz International A tiempo completoAbout the RoleMondelēz International is seeking a highly skilled Site Security Specialist to join our team. As a Site Security Specialist, you will be responsible for ensuring the security and integrity of our industrial automation systems and processes.Key ResponsibilitiesDevelop and implement security protocols to protect against cyber threats and ensure...
-
Site Security Specialist
hace 2 semanas
Ecatepec de Morelos, México Mondelēz International A tiempo completoJob Title: Site Security SpecialistAt Mondelēz International, we are seeking a highly skilled Site Security Specialist to join our team. As a key member of our operations team, you will be responsible for ensuring the security and reliability of our industrial automation and control systems.Key Responsibilities:Develop and implement security policies and...
-
Regulatory and Start-Up Specialist
hace 1 mes
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob OverviewThis position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members.Key ResponsibilitiesParticipate in the development of in-house model process documents.Act as a primary site contact for end-to-end study activity,...
-
Lead Site Monitor
hace 4 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob Overview The role involves conducting monitoring and site management activities to ensure that clinical sites are executing the study protocols and reporting data in compliance with the study guidelines, relevant regulations, and sponsor requirements. Key Responsibilities Conduct site monitoring visits, including selection, initiation, monitoring,...
-
Administrative Assistant to the Site Leader
hace 2 semanas
Ecatepec de Morelos, México Amazon A tiempo completoJob SummaryWe are seeking an Administrative Assistant to support the Site Leader and Fulfillment Center Operations team at Amazon. The successful candidate will be highly organized, extremely detail-oriented, self-motivated, able to handle confidential information, as well as a demonstrated ability to respond effectively to changing workloads and priorities....
-
Site Security Specialist
hace 4 semanas
Ecatepec de Morelos, México Mondelēz International A tiempo completoAbout the RoleWe are seeking a highly skilled Site Security Specialist to join our team at Mondelēz International. As a key member of our operations team, you will be responsible for ensuring the security and reliability of our industrial automation systems.Key ResponsibilitiesOwns all production-related site security and automation systems within a plant...
-
Site Security Specialist
hace 2 meses
Ecatepec de Morelos, México Mondelēz International A tiempo completoAbout This RoleWe are seeking a highly skilled and experienced professional to join our team as a Site Security Specialist at Mondelēz International. This is a critical role that requires a strong background in industrial automation, cybersecurity, and plant security.Key ResponsibilitiesOwns all production-related site security and automation systems within...
-
Clinical Trial Operations Manager
hace 1 semana
Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo**Clinical Trial Management Role**At Syneos Health Clinical, we are seeking a skilled Clinical Trial Manager to oversee site management, clinical monitoring, and central monitoring deliverables for our clients. As a Clinical Trial Manager, you will be responsible for ensuring patient safety, protocol/GCP/regulatory compliance, and data integrity.**Key...
-
Regulatory Affairs and Site Activation Expert
hace 4 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoWe are seeking a Regulatory Affairs and Site Activation Expert to become a part of our FSP team in a remote capacity. Position Overview Engage in activities at a national level related to Site Activation (SA) tasks, ensuring compliance with relevant local and/or international laws, standard operating procedures (SOPs), project specifications, and...