Clinical Trial Manager

1 semana atrás

Lisboa, Lisboa, Portugal Icon Tempo inteiro

As a Clinical Trial Manager sponsor dedicated you will be primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, sponsor's policies and procedures, quality standards and adverse event reporting requirements internally and externally.

For certain studies, the CTM could be responsible for several countries in a cluster.

What you will be doing:

  • Main Point of Contact (POC) for assigned protocols and link between Country Operationsand clinical trial team (CTT).
  • Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet countrycommitments from feasibility and site selection, recruitment, execution and close out.
  • Accountable for performance for assigned protocols in a country in compliance withICH/GCP and country regulations, Sponsor's policies and procedures, quality standards andadverse event reporting requirements internally and externally.o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management asneeded.o Performs Quality control visits as required
  • Leads local study teams to high performance: trains in the protocol other local roles, closelycollaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
  • Responsible for creating and executing a local risk management plan for assigned studies
  • Ensures compliance with CTMS, eTMF and other key systems in assigned studies
  • Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (asappropriate)
  • Responsible for collaboration with functional outsourcing vendors, investigators, otherexternal partners in assigned studies
  • Country POC for programmatically outsourced trials for assigned protocols.
  • Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)
  • Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to alignon key decisions in his/her studies. GHH to be consulted as needed.
  • As a customer-facing role, this position will build business relationships and represent the sponsor with investigators
Shares protocol-specific information and best practices across countries\clustersYou are:

  • Knowledge in Project Management and site management.
  • Strong organizational skills with demonstrated success required.
  • Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD
  • Requires strong understanding of local regulatory environment
  • Strong scientific and clinical research knowledge is required
  • Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
  • Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
  • Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
  • Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
  • Strategic thinkingWhy ICON?Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people.

That's why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.

All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

#J-18808-Ljbffr

  • Associate Manager, Clinical Trials Regulatory Management

    2 semanas atrás

    Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

    Associate Manager, Clinical Trials Regulatory Management (M/W/D) - Home-Based, Emea Lisboa Associate Manager, Clinical Trials Regulatory Management (M/W/D) - Home-Based, EmeaLisboa Lisboa, Lisboa, Portugal col-wideJob Description:Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for...

  • Associate Manager, Clinical Trials Regulatory Management

    2 semanas atrás

    Lisboa, Lisboa, Portugal IQVIA Tempo inteiro

    Associate Manager, Clinical Trials Regulatory Management (m/w/d) Home based, EMEA Lisboa Associate Manager, Clinical Trials Regulatory Management (m/w/d)Home based, EMEALisboa Lisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects....

  • Clinical Trial Associate

    1 semana atrás

    Lisboa, Lisboa, Portugal TFS HealthScience Tempo inteiro

    Overview:TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated CLINICAL TRIAL ASSOCIATE who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.We are a leading global mid-size Contract...

  • Clinical Trial Manager

    1 semana atrás

    Lisboa, Lisboa, Portugal Novasyte Tempo inteiro

    Join us in our exciting journeyIQVIA is expanding in EMEA We currently have a Regional CPM to work sponsor-dedicated to one of our pharmaceutical clientsThe Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level. CTMs contribute...

  • Regulatory Manager, Clinical Trials Regulatory Management- Home-Based, Emea

    2 semanas atrás

    Lisboa, Lisboa, Portugal IQVIA Tempo inteiro

    Regulatory Manager, Clinical Trials Regulatory ManagementHome based, EMEA Lisboa Regulatory Manager, Clinical Trials Regulatory ManagementHome based, EMEALisboa Lisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs...

  • Clinical Trials Associate

    2 semanas atrás

    Lisboa, Lisboa, Portugal TFS HealthScience Tempo inteiro

    Overview:TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated Clinical Trial Associate (CTA) who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.We are a leading global mid-size Contract...

  • Sr Clinical Trial Assistant

    1 semana atrás

    Lisboa, Lisboa, Portugal IQVIA Tempo inteiro

    Clinical Trial Administrator, Single Sponsor dedicated Job Overview: CTA performs daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. By assisting in the coordination and administration of the study activities from the start up...

  • Clinical Supply Chain Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal IQVIA Tempo inteiro

    Clinical Supply Chain Manager (home-based)Lisboa Lisbon, Lisbon, Portugal Job Overview The Clinical Supply Chain Manager is responsible for managing the strategic planning and execution of a program of assigned clinical supply chain projects. The Clinical Supply Chain Manager will support the ongoing development and optimization of the Clinical Trial...

  • Clinical Trial Coordinator

    4 semanas atrás

    Lisboa, Lisboa, Portugal ThermoFisher Scientific Tempo inteiro

    Job DescriptionAt Thermo Fisher Scientific, explore meaningful work with a global impact. Join our team in bringing our Mission to life - helping customers worldwide create a healthier, cleaner, and safer world. We equip our teams with the resources to achieve personal career goals while advancing science through groundbreaking research and life-changing...

  • Clinical Trial Coordinator

    Há 1 mês

    Lisboa, Lisboa, Portugal ThermoFisher Scientific Tempo inteiro

    Job DescriptionAt Thermo Fisher Scientific, explore meaningful work with a global impact. Join our team in bringing our Mission to life - helping customers worldwide create a healthier, cleaner, and safer world. We equip our teams with the resources to achieve personal career goals while advancing science through groundbreaking research and life-changing...

  • Clinical Trial Coordinator

    1 semana atrás

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Clinical Trial Coordinator

    4 semanas atrás

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...

  • Clinical Trial Coordinator

    Há 1 mês

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...

  • Senior Global Clinical Trial Assistant- Portugal

    2 semanas atrás

    Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

    Senior Global Clinical Trial Assistant- Portugal LisboaSenior Global Clinical Trial Assistant- PortugalLisboaLisboa, Lisboa, Portugalcol-wideJob Description:Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential...

  • Senior Global Clinical Trial Assistant- Portugal

    2 semanas atrás

    Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

    Senior Global Clinical Trial Assistant- Portugal Lisboa Senior Global Clinical Trial Assistant- PortugalLisboaLisboa, Lisboa, Portugal col-wideJob Description:Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential...

  • Clinical Trial Coordinator

    2 semanas atrás

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Senior Global Clinical Trial Assistant- Portugal

    2 semanas atrás

    Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

    Senior Global Clinical Trial Assistant- Portugal Lisboa Senior Global Clinical Trial Assistant- PortugalLisboa Lisboa, Lisboa, Portugal col-wideJob Description:Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential...

  • Local Trial Manager

    1 semana atrás

    Lisboa, Lisboa, Portugal Amgen Tempo inteiro

    Career CategoryClinical DevelopmentJob Description:HOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you areAt Amgen, our shared mission—to serve patients—drives all that we do, which is the key for us to becoming one of the world's leading biotechnology companies. We are global collaborators who achieve...

  • Senior Global Clinical Trial Assistant- Portugal

    2 semanas atrás

    Lisboa, Lisboa, Portugal Iqvia Llc Tempo inteiro

    Senior Global Clinical Trial Assistant- Portugal page is loaded Senior Global Clinical Trial Assistant- Portugal Apply locations Lisbon, Portugal time type Full time posted on Posted 2 Days Ago job requisition id R Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a...

  • Local Trial Manager

    2 semanas atrás

    Lisboa, Lisboa, Portugal Amgen Inc. (Ir) Tempo inteiro

    Local Trial Manager - Multiple openings page is loaded Local Trial Manager - Multiple openings Apply remote type Remote locations Portugal - Lisbon time type Full time posted on Posted Yesterday job requisition id R Career CategoryClinicalJob Description If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to...