Senior/clinical Data Team Lead, Iqvia Biotech

hace 5 días


Buenos Aires, Argentina Novasyte A tiempo completo

Join our team as a Senior Data Team Lead, IQVIA Biotech
- Senior Data Team Lead position is to manage all data management (DM) tasks to include more complex and/or larger studies and/or a program of studies from start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.- Essential Functions:
- Manages DM-related aspects of the program and/or project
- Collaborates with the project team on overall data management strategy for the program and/or projects, assuring overall quality and efficiency
- Represent DM as the functional lead at internal and sponsor project team meetings
- Provides proactive, timely communication of project status, data trends and issue resolution with internal team and Sponsor
- Develops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and Sponsor
- Assumes ownership for DM project deliverables within DM scope of services including creation and management of DM-specific timelines and providing resource and budget projections
- Discusses roadblocks to DM deliverables and potential strategies for overcoming with project team and/or DM management and implements solutions
- Performs peer reviews of key DM study documents or other DM deliverables to assure quality of content and, where appropriate, consistency across a program of studies
- Reviews and provides DM staffing projections for program and/or projects
- Presents EDC and/or CRF completion at Investigator Meetings
- Participates in regulatory and Sponsor audits for program and/or projects
- Oversees daily team member activities
- Serves as a Data Management team leader
- Assures project activities are performed within budget and according to expected timelines and meet high quality standards.
- Reviews resource allocation with the assigned DM project leads to ensure projects and budgets are managed effectively
- Data Reconciliation (e.g., Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and/or 3rd party vendors
- Investigation and remediation of reviewer-reported data issues such as from statistical, medical or Sponsor reviews
- Oversees System Development and Modifications
- Oversees System and Data Listing Testing Activities.
- Develops, Maintains and Archives DM Project Documentation including.- Represents Data Management at Bid Defense Meetings (BDM)
- Recommends and assists in the development of standards and/or improvements to existing standards including processes, CRFs, data listing reports and document templates- Occasional travel for Bid Defense Meetings, Investigator Meetings, client face-to-face meetings, user group meetings or training courses. Travel not anticipated to exceed 2-3 times per quarter.
- Qualifications:
- Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification
- +5 years of experience in clinical trials within a similar function.
- Advanced level of English
- Proven competence in managing delivery of multiple projects / programs independently through full data management study life-cycle
- Experience in handling bid defense meetings
- Proficiency with multiple clinical EDC systems (preferred systems are InForm and Rave)
- #LI-RemoteIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at



  • Buenos Aires, Argentina IQVIA A tiempo completo

    **BASIC FUNCTIONS**: Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    ** Experience managing clinical trials in LATAM and North America(REQUIRED)**: - ** Strong Cardiovascular Therapeutic experience**: - **3+ years of Clinical Trial Management experience (CRO experience preferred)** **BASIC FUNCTIONS**: Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities....


  • Buenos Aires, Argentina IQVIA A tiempo completo

    Project Management Analysts (PMA) are an integral part of clinical trial delivery, liaising with project teams to improve patients’ lives by bringing studies to the market faster. The Sr. PMA works in close partnership with the Project Leader (PL)/Clinical Project Manager (CPM) driving project management activities to mitigate risk, control cost, manage...


  • Buenos Aires, Buenos Aires C.F., Argentina IQVIA A tiempo completo

    About the RoleWe are seeking a highly skilled Medical Director to provide medical, clinical, and scientific advisory expertise to all IQVIA divisions as requested. The successful candidate will have a strong background in general clinical medicine and experience in the Pharma, CRO, or Biotech industry.Key ResponsibilitiesMedical Monitoring: Provide medical...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    Unleash Your Potential It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward. Join IQVIA and see where...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    POSITION TITLE: Regulatory Affairs Specialist REPORTS TO: Manager, Regulatory Affairs or Designee BASIC FUNCTIONS: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance,...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    Job Description Summary Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    IQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support. Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager. Previous clinical trial management and CRO experience preferred. Therapeutic requirements/preference: any of the following Oncology/Hematology/CAR T/Cell &...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    POSITION TITLE: Senior Project Manager REPORTS TO: Director, Project Management or Designee BASIC FUNCTIONS: Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the...


  • Buenos Aires, Buenos Aires C.F., Argentina IQVIA A tiempo completo

    Job OverviewThe Pharmacovigilance and Case Intake Specialist/Operations Specialist 1 plays a crucial role in ensuring the quality and integrity of safety data. This position involves distributing reports/data to internal and external parties, following regulations, SOPs, and guidelines with support from senior team members.Responsibilities include collecting...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    Join our team as a Principal/Senior Data Team Lead Job Overview Senior Data Team Lead position is to manage all data management (DM) tasks to include more complex and/or larger studies and/or a program of studies from start-up through database closure and archival producing high-quality databases for analysis and potential regulatory...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    **BASIC FUNCTIONS**: Provides project-related support to the Program, Senior, and Project Manager(s) and other project team members from proposal development through final deliverable. **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**: - Manages projects of limited scope (functional or regional). Responsible for project team leadership. -...


  • Buenos Aires, Buenos Aires C.F., Argentina IQVIA A tiempo completo

    Job OverviewIQVIA creates intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.As a Senior Clinical Trial Manager, you will be responsible for the delivery and management of smaller, less complex regional studies.Key...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    Job Overview Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance...


  • Buenos Aires, Buenos Aires C.F., Argentina IQVIA A tiempo completo

    Driving Healthcare InnovationIQVIA accelerates innovation to create a healthier world. Delivering on this ambition requires connecting our capabilities, expertise, and people. Every day, we work together to drive healthcare forward in ways both big and small, helping customers solve problems and improving patient outcomes.Join IQVIA as a Global Trial Manager...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to...

  • Clinical Lead

    hace 2 semanas


    Buenos Aires, Argentina Novasyte A tiempo completo

    Calling ALL experienced Clinical Leads. The Clinical Lead provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in...


  • Buenos Aires, Buenos Aires C.F., Argentina IQVIA LLC A tiempo completo

    Company Overview:IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health...