Site Activation Partner

hace 6 meses


En remoto, España Parexel A tiempo completo

Spain, Remote

**Job ID** R0000015394

**Category** Clinical Trials

**ABOUT THIS ROLE**:
The FSP division of Parexel FSP is seeking a Site Activation Partner based in Spain.

**Position Purpose**:

- The Site Activation Partner 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 than 1 country depending on the geographical region and business needs

**Primary Responsibilities**:
Clinical Trial Site Activation
- Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation
- Register investigator sites and Client stakeholders in Client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status
- Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable
- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
- Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements
- Coordinate the timely communication, documentation and responses between Client and Central Ethics committee to bring clinical study to approval (country dependent)
- Support investigators sites with local IRB workflow from preparation, submission through approval
- Assist with preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as needed
- Collaborate with the Study Team on the development and readiness of sites electronic Investigator Site File (eISF) when utilized and act as primary point of contact for the sites and manage the Site Operations/CRO monitor access to eISF prior to Site Initiation Visit (SIV)
- Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- Support & implement activities in SIP to align with Client strategy as it relates to the role
- Coordinate translation of documents that are within scope with the preferred translation vendors

Clinical Trials Conduct
- Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals and other activities required during study conduct
- Ensure maintenance of IRB/Ethics and other committees’ activities as applicable
- Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness
- Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
- Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections

Clinical Trial Site Support
- As needed, perform, awareness session with site personnel on Client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Client standards
- Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues

General
- Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system and process related training
- Adhere to EP and Client SOPs and processes
- A good understanding of the Site Activation requirements and processes within the country/region and be able to learn and potentially implement in more than one (1) country

Additional Responsibilities
- May be assigned as Site Activation Partner Point of Contac



  • En remoto, España Parexel A tiempo completo

    Spain, Remote **Job ID** R0000015136 **Category** Clinical Trials **ABOUT THIS ROLE**: Additional Job Description In Parexel FSP we are looking for a Site Activation Partner based in Spain. **Position Purpose**: - The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies...


  • En remoto, España Parexel A tiempo completo

    Spain, Remote **Job ID** R0000017249 **Category** Clinical Trials **ABOUT THIS ROLE**: In Parexel FSP we are looking for a Site Activation Partner based in Spain. **Position Purpose**: - The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to...


  • En remoto, España IQVIA A tiempo completo

    Job Overview Under general supervision, perform tasks at a country/region 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 feasibility or maintenance activities. Essential...


  • En remoto, España ICON A tiempo completo

    As a S **ite engagement Liason **you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: **Accountable for site start-up and activation** - Deploy GSSO site strategies by qualifying and activating assigned sites - Supports processes to optimize country &...


  • En remoto, España ICON A tiempo completo

    As a Site Engagement Liaison you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - Responsible for site and monitoring quality, regulatory and GCP compliance. - Drive inspection readiness and provide support for site audits/inspections as needed,...


  • En remoto, España Pfizer A tiempo completo

    The Study Operations Manager II is responsible for study and regional/country level activities from study startup through conduct and study close. The Study Operations Manager will be assigned one or more studies and will be tasked with taking on several responsibilities in support of the larger Study Management deliverables. The Study Operations Manager II...

  • Site Manager

    hace 5 meses


    En remoto, España FieldCore A tiempo completo

    **Job Summary**: Site Manager - Outage is responsible for preparation, planning, leading execution, and close out of complex project/outages events for gas turbine, steam turbine and generator power plants while supporting the development of the business strategy for field fulfilment excellence in FieldCore. The Site Manager - Outage is a focal role, with...


  • En remoto, España IQVIA A tiempo completo

    **Associate Study Start-Up Manager** **IQVIA Biotech** Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. **Essential Functions**: - Oversee the execution of Site...

  • Director, Start-up

    hace 6 meses


    En remoto, España Innovaderm Research A tiempo completo

    The Director, Start-Up is responsible for providing leadership and oversight to site contracting, and site activation teams, ensuring alignment with study and site activation timelines. The Director, Start-Up will provide leadership to functional leads of Site Selection and Site Contracting. The Director, Start Up has line management responsibility for...


  • En remoto, España IQVIA A tiempo completo

    **Job Overview** Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. **Fluent in Spanish and English.** **Essential Functions** - Oversee the execution of Site Activation...

  • Contract Analyst

    hace 6 meses


    En remoto, España ICON A tiempo completo

    As a Contract Analyst you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The Contract Analyst works with crossfunctional team members on development of the study CTA/budget templates and escalation of language or costs that cannot be agreed to in the negotiation process. The...


  • En remoto, España Innovaderm Research A tiempo completo

    The Associate Project Manager ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects. The Associate Project Manager must ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical...


  • En remoto, España Parexel A tiempo completo

    The **Initiation Clinical Research Associate II **(**iCRA II**) specialises in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCRA II can also support protocol amendments if...


  • En remoto, España Allucent A tiempo completo

    These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in...

  • Senior Project Manager

    hace 6 meses


    En remoto, España ICON A tiempo completo

    As a Clinical Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - The Study Operations Manager is responsible for study and regional/country level activities from study startup through conduct and study close. The Study Operations...


  • En remoto, España IQVIA A tiempo completo

    We are looking for Project Leader/ Senior Project Leader’s to join our innovative and dynamic group of global professionals dedicated to assisting our clients in driving healthcare forward. This is an important and high-profile role within our Research & Development Operation business unit to enable medical breakthroughs that advance healthcare and patient...

  • Change Manager

    hace 5 meses


    En remoto, España Adroit People Ltd A tiempo completo

    **Main Function** We are looking for an Adoption Lead role who will be an integral part of the myBuy program. The Adoption Lead will be responsible to ensure that all OCM aspects of the myBuy deployment are taken into consideration, understood and followed. The Adoption Lead will be looking after a core site or RSS cluster and will ensure that the OCM...

  • Senior Study Manager

    hace 5 meses


    En remoto, España Parexel A tiempo completo

    Spain, Remote **Job ID** R0000014735 **Category** Clinical Trials **ABOUT THIS ROLE**: **Position Purpose**: - The Senior Study Manager (SSM) has responsibility for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies - The SSM leads and manages the tactical execution of one or more...

  • Head of Sme Success

    hace 6 meses


    En remoto, España Birdie A tiempo completo

    **About Birdie** Birdie is the leading home healthcare technology platform that aims to radically transform the lives of older adults. Its all-in-one solution supports millions of care visits every month, equipping care providers with the tools they need to deliver better quality care and improve efficiency across most day-to-day operations. Birdie is...


  • En remoto, España Allucent A tiempo completo

    These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in...