Regional Clinical Trial Management Associate

hace 1 mes

Alcobendas, España Beigene A tiempo completo

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.
When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards, within timelines and budgetBuilds solid knowledge of clinical trials operations in the region under guidance of the Regional Clinical Study ManagerSupports the alignment of regional deliverables with overall study goals under the direction of the Regional Clinical Study ManagerEssential Functions of the job: Regional Trial Support & CollaborationDevelops regional study management experience by supporting to oversee multiple aspects of clinical trial conduct including feasibility assessment, study start-up, document generation and review, tracking of samples and enrollment of study participants.Acquires solid knowledge of clinical research operations, including interpretation and implementation of regulations/ICH guidelinesSupports the Regional Clinical Study Manager with set up and logistics of regional team meetings (agenda, minutes, ..)Establishes good collaboration with Regional Clinical Study Manager, the Global Study Management Associate and other key stakeholders regionally and globallyAs required, supports CRAs with various activities such as monitoring visit preparations, TMF filing, ..Timelines, Planning and ExecutionCreates and maintains regional/country level SharePoint folders for the study and regional study team distribution listsSets up the countries and sites in the region in the appropriate systems e.g.
eTMF, CTMS, ..and makes sure information is kept up to dateSupports system access requests for the region/country and ensure these are managed appropriately across the study life cycle, supports user account management for users in regionMight support the local adaptation of global documents under supervision of the Regional Clinical Study ManagerMay assist in the review of study-related documents as they relate to the supported clinical trials as delegated by the Regional Clinical Study Manager (e.g., Informed consent forms, regional Pharmacy Manual, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and other relevant regional study plans and charters)Supports study start up in region/country in close collaboration with the regional study start up team and the Regional Clinical Study ManagerSupports the organization of study specific investigator meetings together with the Regional Clinical Study Manager and the Global Study Management AssociateSupports the TMF specialist with country/site level TMF creation and maintains the country/site level TMF including regular review and QC of TMF documents as per the study TMF QC planHelps resolving any regional/country specific issues related to clinical supplies in collaboration with relevant stakeholdersdSupports the data cleaning activities and contributes to the follow up of outstanding information for region/countryPrepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study teamMight assist in resolution of routine study questions from clinical trial sitesMight support the maintenance of information for region/country in relevant public registries (e.g CT.gov)Supports the Regional Clinical Study Manager with providing all relevant information from region/country to be included in the Clinical Study ReportQualitySupports the identification of operational risks and works with the Regional Clinical Study Manager to recommend solutions for discussion with appropriate team leadershipLearns and shares best practices in clinical operations methodologies, systems and processes with the emphasis on quality and complianceMight support the preparation of sites for quality assurance audits and inspectionsSuggests improvements to enhance the efficiency and the quality of the work performed on assigned projectsMight support the development of local/regional tools, working instructions and SOPsBudget Supports set up of vendors for activities outsourced in region/countrySupports management of regional study budget incl PO set upSupports PO set up for regional vendorsEducation Required: Bachelor's Degree in a scientific or healthcare discipline required*, Higher Degree preferred*exceptions might be made for candidates with relevant clinical operations experienceSupervisory Responsibilities: N/AComputer Skills: MS OfficeOther Qualifications: Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes1 or more years of experience in clinical research within biotech, pharma or CRO industryTravel: Limited travel might be requireBeiGene Global CompetenciesWhen we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

  • Regional Clinical Trial Management Associate

    hace 1 mes

    Alcobendas, España BeiGene A tiempo completo

    BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Supports the Regional...

  • Regional Clinical Trial Management Associate

    hace 3 meses

    Alcobendas, España BeiGene A tiempo completo

    BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Job Description Only Applicants with a valid work...

  • Initiation Clinical Research Associate

    hace 3 meses

    Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.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...

  • Initiation Clinical Research Associate

    hace 3 meses

    Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.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...

  • Clinical Trial Operations Expert

    hace 2 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Company OverviewParexel FSP is a global biopharmaceutical services company dedicated to helping clients accelerate innovation. With a key mission to prevent and treat disease by bringing important new medicines and therapies to patients in need, Parexel FSP relies on the expertise, experience, innovation, and commitment of its employees around the world.Job...

  • Clinical Research Associate Ii

    hace 3 meses

    Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health.We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...

  • Clinical Research Associate Ii

    hace 3 meses

    Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...

  • Clinical Research Associate Ii

    hace 3 meses

    Alcobendas, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...

  • Clinical Research Lead

    hace 2 semanas

    Alcobendas, España Eli Lilly And Company A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Clinical Research Lead

    hace 2 semanas

    Alcobendas, España Lilly A tiempo completo

    .At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Clinical Research Lead

    hace 2 semanas

    Alcobendas, España Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Clinical Research Lead

    hace 7 meses

    Alcobendas, España Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Clinical Research Lead

    hace 2 semanas

    Alcobendas, España Eli Lilly and Company A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Clinical Research Lead

    hace 2 semanas

    Alcobendas, España Eli Lilly and Company A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Global Clinical Research Strategist

    hace 2 días

    Alcobendas, Madrid, España Eli Lilly And Company A tiempo completo

    Job SummaryWe are seeking a skilled Global Clinical Research Strategist to join our team at Eli Lilly and Company. This is a challenging role that requires strong leadership skills, strategic thinking, and the ability to drive clinical trial programs forward.About the RoleThe successful candidate will be responsible for managing clinical sites, identifying...

  • Clinical Research Lead

    hace 2 semanas

    Alcobendas, España Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Project Manager/Senior Project Manager

    hace 8 meses

    Alcobendas, España Precision Medicine Group A tiempo completo

    Are you an experienced full service Project Manager in the field of clinical trials who’s engaged in addressing the challenges facing the research and development of novel compounds in Oncology, Rare Disease or CNS? Are you passionate about impacting the health and lives of patients around the world? Do you take a consultative approach to trial management,...

  • Business Development Associate

    hace 1 mes

    Alcobendas, Madrid, España Hollister Incorporated A tiempo completo

    Job SummaryWe are seeking a highly motivated and detail-oriented Business Development Associate to join our team in Madrid, ES. As a Business Development Associate - Clinical Event Coordinator, you will play a critical role in supporting the growth and development of our business by coordinating clinical events and projects.Key ResponsibilitiesDevelop and...

  • Clinical Research Associate II Professional

    hace 2 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Role OverviewIn this role, you will have the opportunity to make a meaningful impact on the development of life-changing treatments for patients. As a Clinical Research Associate II at Parexel, you will be responsible for conducting qualification visits, site initiation visits, monitoring visits, and termination visits at assigned clinical sites.You will...

  • Senior Clinical Data Manager/Principal Clinical Data Manager

    hace 6 meses

    Alcobendas, España Precision Medicine Group A tiempo completo

    Position Summary:The Senior Clinical Data Manager/Principal Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be...