Site Activation Manager

hace 2 semanas


En remoto, España IQVIA A tiempo completo

Project manager for the start-up phase in charge of design and implementation of the strategy towards site activation from award until open to enrollment. Lead and oversee the country operations teams ensuring client commitments are delivered timely and according to project scope and processes.

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 Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
- Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
- Ensure collaboration across Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope.
- Create and/or review technical and administrative documentation to support business development and enable study activation and maintenance, as required.
- Provide technical and scientific support to facilitate efficient business development.
- Initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
- Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the Study Management Team.
- Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of site activation.
- Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
- Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review and negotiation of contracts and essential documents.
- Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
- Mentor and coach colleagues as required.
- Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
- May take a lead role in developing long standing relationships with preferred IQVIA customers.
- Deliver presentations/training to clients, colleagues and professional bodies, as required.
- May be involved in activities related to monthly study budget planning and reviews.



  • 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...


  • 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. **Essential Functions** - Oversee the execution of Site Activation (including pre-award/bid defense...

  • Project Coordinator

    hace 4 semanas


    En remoto, España Innovaderm Research A tiempo completo

    The Project Coordinator works with Project Managers, Clinical Trial Managers, Site Selection Team and Clinical Research Associates (CRA) to provide administrative and coordinating support for site activation activities and other site level deliverables through all phases of the clinical trial lifecycle. As a Project Coordinator, you will take the lead to...

  • Site Contracts Lead

    hace 7 días


    En remoto, España Premier Research A tiempo completo

    Bring your Passion to Premier! Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices. We’re looking...

  • Senior Project Manager

    hace 4 semanas


    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. **We are looking for experienced Project Managers with substantial experience in multi-country/global PM experience.** **What you will be doing**: - The Study Manager has responsibility 1 or more...

  • Global Regulatory Manager

    hace 4 semanas


    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 Study Manager

    hace 4 días


    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...


  • 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...


  • En remoto, España Parexel A tiempo completo

    The **Initiation Clinical Research Associate (iCRA)** 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 I can also support protocol amendments if applicable. This...


  • En remoto, España IQVIA A tiempo completo

    You will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. The role may also include maintenance activities. This is not a line management position but requires...


  • En remoto, España Parexel A tiempo completo

    Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction. As a CRA...

  • Mcu Commissioning Tech

    hace 4 semanas


    En remoto, España Renewable Energy Onshore Wind A tiempo completo

    **Job Description Summary**: While on site reports to the MCU Lead Tech, Ensures all turbines are commissioned in accordance with GE Energy established procedures and safe work practices. The MCU Commissioning Technician is responsible for electrical preparation, LOTO, troubleshooting and commissioning activities during Major Component Upgrade (MCU)...

  • Content Manager

    hace 4 semanas


    En remoto, España PVcase, UAB A tiempo completo

    **About the role**: The technical educational content manager is tasked with developing educational courses (text and video) for our engineering software products in accordance with the expected use of the product and best educational practices. The content is expected to be maintained on a regular cycle. The content manager should monitor changes and plan...

  • Sap

    hace 4 semanas


    En remoto, España Red Commerce A tiempo completo

    On behalf of our global client, here at RED we are looking for a Product Manager join a brand new project. **Responsibilities**: The product manager identifies the customer need and the larger business objectives that the product will fulfil and articulates what success looks like for this product. This professional will also be responsible for the product...


  • En remoto, España Voggt A tiempo completo

    Who are we? Voggt is on a mission to create the most entertaining collectibles trading experience online by reinventing the way people manage and grow their passions. We make it fun and safe for buyers and sellers to engage while seamlessly trading on our livestream auction marketplace. Voggt has massive potential, with thousands of sellers and collectors...


  • En remoto, España MSF International A tiempo completo

    **Location**: Any MSF office* **Contract**: Permanent, Full-time **Starting date**: ASAP **Deadline to apply**: 23 May 2024 **Compensation and benefits**: MSF practice is to offer the C&B package current in the MSF entity establishing the contract.**I. MSF INTERNATIONAL** Médecins Sans Frontières (MSF) is an international, independent, medical...


  • En remoto, España Jensen Localization A tiempo completo

    Job description We at Jensen Localization are looking for native in-house Scandinavian translators (Danish, Finnish, Norwegian or Swedish) willing to work remotely or in site at our Málaga office (Spain). Tasks As an in-house translator you will be responsible for the translation, revision and/or post-edition of texts from English into your native...

  • Freelance Product Manager

    hace 4 semanas


    En remoto, España Resident Advisor A tiempo completo

    Resident Advisor is the world’s foremost platform for discovering electronic music, artists and events. Described by the NY Times as “the most influential electronic music site in the world”, every month RA reaches more than 5m people across its web, mobile and app properties. We are looking for a freelance product manager to support the product team...

  • Performance Marketing

    hace 7 días


    En remoto, España Bitfinex A tiempo completo

    The Performance Marketing and Customer Acquisition Manager will be responsible for implementing and measuring all Bitfinex marketing efforts to ensure optimization for return on investment and conversion. He or she will also be responsible for delivering strategies to bring in experienced retail and professional traders, utilizing token listing activation...

  • Performance Marketing

    hace 4 semanas


    En remoto, España Bitfinex A tiempo completo

    The Performance Marketing and Customer Acquisition Manager will be responsible for implementing and measuring all Bitfinex marketing efforts to ensure optimization for return on investment and conversion. He or she will also be responsible for delivering strategies to bring in experienced retail and professional traders, utilizing token listing activation...