Senior Site Activation Lead

hace 8 meses

Ciudad de México ICON plc A tiempo completo

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 organizations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

**General Summary**
The Start-Up Lead (SUL) leads regional clinical study start-up activities to ensure successful activations of investigative sites in accordance with protocol, budget, standard operating procedures, policies and applicable regulations. Ensures optimal quality delivery for assigned sites’ readiness to enroll, meeting sponsor satisfaction to timelines. Proactively identifies and mitigates risks and resolves issues, escalating appropriately.
- Creates, maintains and facilitates Sponsor Approval of project documents related to study start-up, including the Essential Document Templates, Essential Document Review Requirements, Country and Site Standard Investigational Product Release forms.
- Creates, maintains and facilitates Client Approval of project status reports.
- Prepares and presents a project-specific overview to Clinical Operations, Investigator Grant Management and Global Regulatory Affairs staff regarding start up deliverables, timelines and processes.
- Oversees site identification and recruitment activities for allocated countries; including, liaising with other departments when additional sites are needed, and escalates delays, where applicable.
- Oversees the Local Regulatory Affairs Lead (LRAL), Contracts Associate (CA) and In
- House Clinical Research Associate (IHCRA) to ensure that essential documents for allocated regions are developed, collected, reviewed and tracked according to the processes and timelines agreed upon on the project.
- Collaborates with the Global Regulatory Affairs Lead (GRAL) assigned to the project to ensure Ministry of Health (MoH), Central Independent Ethics Committee (IEC) and other central submissions are performed in line with site activation timelines.
- Collaborates with the GRAL and Clinical Team Manager (CTM) assigned to the project to ensure importation, exportation, insurance, labeling of Investigational Product (IP) and any other country requirements are met to ensure the timely activation of trial sites.
- Oversees Local Ethics Committee (IEC) and other local authority submissions and approvals for their country/region or the project as applicable.
- During Start-Up, works with GRAL/ LRALs and/or IHCRA(s) to ensure quality amendments and submissions are made (where applicable).
- Performs Independent QC of Investigational Product Release packages and other documentation (i.e. Essential Documents and Informed Consent Forms) as determined by project specific process.
- Oversees system compliance from the IHCRAs and works with the GRAL and/or CTA Lead to address any system compliance issues from the LRAL/CA.
- Serves as primary liaison and primary point of escalation for project start-up issues for assigned countries.
- Conducts meetings to ensure all relevant team members are properly trained on start-up activities and kept current on timelines, clinical activities and contract and budget status.
- Uses available tools, including but not limited to the Critical Chain Methodology tool to establish site activation forecasts and ensures critical path activities are on target. Also oversees the completion of the system’s activities with the support of the CTM, GRAL and CTA Lead where necessary.
- Escalates risks to project start-up timelines for assigned countries and works with the CTM and/or Project Manager (PM) to mitigate those risks.
- For assigned countries, provides timely status reports on project start-up activities for internal and client teleconferences, and during monthly project review meetings with the SSU VP, Directors and Managers.
- With support from the CTM, ensures Time Entry Guidelines are adhered to by the IHCRA, determines worked hours and analyzes forecasted and worked activities to ensure adherence to contract and budget.
- Assesses and communicates impact of project scope on timeline changes and/or local resource requirements and escalates where necessary.
- Assists the CTM, CTA Lead, GRAL and/or PM with the forecast of units and hours and generic resourcing for IHCRA, LRAL and CA activities; determines worked units and hours and analyzes forecasted and worked activities to ensure adherence to contract and budget, as required.
- Facilitates the transition of study activities and status to the CTM and Clinical Research Associate (CRA) as sites/countries move out of Start-up and into Conduct.

**Bene

  • Senior Site Activation Lead

    hace 1 semana

    Ciudad de México ICON Plc A tiempo completo

    Senior Site Activation Lead 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 Senior Site Activation Lead to join our...

  • Site Activation Lead

    hace 2 semanas

    Ciudad de México ICON Plc A tiempo completo

    SAL 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 Activation Lead to join our diverse and dynamic team. As a...

  • Senior Site Activation Lead

    hace 3 meses

    Ciudad de México, CDMX Icon plc A tiempo completo

    Sr. SAL (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 development At ICON, it’s our people that set us apart. Our diverse teams enable us to...

  • Site Activation Coordinator

    hace 7 meses

    Ciudad de México IQVIA A tiempo completo

    **Job Overview** Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Essential Functions** - Under...

  • Site Activation Specialist

    hace 6 meses

    Ciudad de México Novasyte A tiempo completo

    Job Overview Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors;...

  • Site Activation Coordinator

    hace 2 meses

    Ciudad de México, CDMX IQVIA A tiempo completo

    Job Overview Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general...

  • Site Activation Manager

    hace 2 semanas

    Ciudad de México, Ciudad de México Syneos Health Commercial Solutions A tiempo completo

    Unlock Your Potential as a Site Activation ManagerWe are seeking an experienced and skilled Site Activation Manager to join our team at Syneos Health Commercial Solutions. As a key member of our organization, you will be responsible for ensuring the successful start-up and activation of clinical trials sites, while collaborating with cross-functional teams...

  • Manager, Site Activation

    hace 2 meses

    Ciudad de México, CDMX Icon plc A tiempo completo

    SAM (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 development At ICON, it’s our people that set us apart. Our diverse teams enable us to...

  • Site Activation Partner I

    hace 4 semanas

    Ciudad de México, CDMX Parexel A tiempo completo

    The Site Activation Partner I (SAP I) is responsible for leading or supporting operational activities from start up to close out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client standards. Responsibility within a country and may span over more...

  • Study Start Up Associate Ii

    hace 2 meses

    Ciudad de México, CDMX Icon plc A tiempo completo

    Study Start Up Associate II (Site Activation Associate) - Mexico - Homebased 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 At ICON, it’s our...

  • Manager, Site Activation

    hace 1 mes

    Ciudad de México, CDMX ICON Plc A tiempo completo

    Site Activation Manager (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 development At ICON, it’s our people that set us apart. Our diverse...

  • Site Activation Manager Ii

    hace 7 meses

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **Site Activation Manager 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...

  • Study Start Up Associate I

    hace 2 meses

    Ciudad de México, CDMX Icon plc A tiempo completo

    Study Start Up Associate I & II (Site Activation Associate) - Mexico - Homebased 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 At ICON, it’s...

  • Site Activation Lead Contracts

    hace 1 mes

    Ciudad de México, CDMX Icon plc A tiempo completo

    SAL Contracts 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 At ICON, it’s our people that set us apart. Our diverse teams enable us to become...

  • Senior Site Activation Lead

    hace 6 días

    Ciudad de México ICON Plc A tiempo completo

    Sr. SAL 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 INSERT ADVERT TEXT HERE What ICON can offer you: - Our success depends on the quality...

  • Senior Site Activation Lead

    hace 6 días

    Ciudad de México ICON Plc A tiempo completo

    Sr. SAL 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 development What ICON can offer you: - Our success depends on the quality of our people....

  • Site Care Partner

    hace 1 mes

    Ciudad de México, CDMX Pfizer A tiempo completo

    The Site Care Partner is the main Pfizer point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site-level...

  • Site Contracts Specialist

    hace 2 semanas

    Ciudad de México IQVIA A tiempo completo

    **Job Overview** Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors;...

  • Site Activation Project Manager

    hace 3 semanas

    Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

    **About the Role**We are seeking an experienced Site Activation Project Manager to join our team at Syneos Health Clinical. In this role, you will be responsible for overseeing the site start-up process, ensuring that all regulatory activities are completed on time and within budget.**Responsibilities**Collaborate with major functional areas including...

  • Sr. Site Activation Manager Sponsor Dedicated Home

    hace 2 semanas

    Ciudad de México, Ciudad de México Syneos - Clinical And Corporate - Prod A tiempo completo

    About the RoleWe are seeking a highly skilled Sr. Site Activation Manager Sponsor Dedicated Home to join our team at Syneos Health, a leading fully integrated biopharmaceutical solutions organization.Key ResponsibilitiesCollaborate with major functional areas, including Business Development, Alliance Management, Contracts and Proposals Development, and...