Lead eClinical Systems Analyst - Pune - TransPerfect

    TransPerfect
    TransPerfect Pune

    1 day ago

    Description

    OVERVIEW

    The Lead eClinical Systems Analyst is a senior line management role. This role is responsible for assisting clients with the development, maintenance and closeout of clinical trials, using a number of eClinical systems including but not limited to: e TMF, Study Start up (SSU) and Clinical Trial Management System (CTMS). This role assists clients with trial management, as required by our clients. The person in this position is someone who is highly experienced with eClinical systems, particularly the clinical trial process around the quality of the TMF. The Lead eClinical Systems Analyst has good knowledge of clinical trial processes and associated systems utilized, with

    core skills around all clinical processes they work on multiple projects to ensure a complete, contemporaneous and accurate TMF across our clients' clinical trials and programs.


    DESCRIPTIO

    • NLine management, coaching and mentoring of eClinical Analysts in the assigned location/
    • sOversee, create and complete billable TMF quality reviews to ensure document content and metadata application is accurate and to ensure documentation is present/complete in the TM
    • FOversee periodic quality reviews for each active study site for all regulatory documents, including: IRB Renewal, IRB Protocol Approval, Informed Consent Review, Signature of Co-Investigator, IRB Membership list, Lab Normal, CAP, CLIA, 1572 Form, Agreements, PI CV
    • sAssist in regulatory document review and compilation of documents for FDA submissions using GCP and ICH guideline
    • sDraft, review and approve TMF Quality plans and reports and reconciliation of finding
    • sCommunicate all systematic filing issues to manager for further training evaluatio
    • nMay work with Study Owners (SO) with all start up, maintenance and close out activities in regards to the TMF eTMF ongoing user managemen
    • tMay be responsible for creation and or maintenance of events/placeholders or equivalent in the eTM
    • FIdentify and report to SO/Clinical Document Lead /Project Manager/Client/Line Manager on TMF trending issues/concerns, determining resolutions and course of action
    • sProvide support on metrics and report preparation for TMF Key Performance Indicators (KPIs) - completeness, quality and timeliness to senior leadership tea
    • mComplete all other tasks that are deemed appropriate for this role and assigned by the manager/superviso

    rJob requirement

    sREQUIRED SKILL

    • SSuperior communication skills in English (verbal and written
    • )Ability to effectively multitask in order to simultaneously execute multiple project
    • sSuperior problem-solving/critical thinking skill
    • sAbility to maintain professionalism in all situations, especially under tight deadline
    • sSuperior interpersonal skill
    • sSuperior proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint
    • )Excellent managerial/leadership skill

    s
    REQUIRED EXPERIENCE AND QUALIFICATIO

    • NSMinimum of 5 years of experience in the Life Sciences industry (pharmaceutical, biotechnology or C
    • ROexperience preferre
    • d)Strong experience with TMF documents including creation, tracking, implementation, maintenance, a
    • ndelectronic filing and
    • QCExperience in the use and development of hard copy files/electronic documentation and electronic T
    • MFStrong working knowledge of ICH/GCP Guidelin
    • esKnowledge of clinical development phases and process
    • esLine management or team lead experien

    ce
    DESIRED SKILLS AND EXPERIE

    • NCEAbility to build relationships with clients and co-work
    • ersDetail-orientated and well organi
    • zedCritical thin
    • kerExperience working with eTMF or other eClinical systems such CTMS, SSU, eTMFs as Veeva Vault or Wingspan IQVIA
    • TMFSuperior knowledge of the CDISC TMF Reference Mo
    del
  • Work in company

    System Analyst

    Only for registered members

    This position is open with Bajaj Finance ltd. The Objective of the individual is to deliver a payment gateway which should be at par with the industry. · ...

    Pune

    1 week ago

  • Work in company

    System Analyst

    Only for registered members

    Proactive and detail-oriented project manager with hands-on experience in managing cross-functional teams and delivering projects on time. · ...

    Pune

    1 month ago

  • Work in company

    Systems Analyst II

    Only for registered members

    The Systems Analyst will support and enhance MasterCard's financial systems by conducting requirements analysis, participating in solution design, and performing application development. · ...

    Pune, Maharashtra

    1 month ago

  • Work in company

    Business Systems Analyst

    Only for registered members

    We are seeking a Business Systems Analyst to join our global IT team.Bridge the gap between business needs and technical solutions. · ...

    Pune, India

    4 days ago

  • Work in company

    Senior Systems Analyst

    Only for registered members

    We are looking for a Senior Enterprise Systems Analyst to join our global team and help take Convera's Cloud strategy to the next level.Identify, develop, and implement solutions for various business initiatives that utilize various software applications such as Oracle FUSION (ER ...

    Pune Full time

    1 month ago

  • Work in company

    Business Systems Analyst

    Only for registered members

    We are seeking a Business · Sys-tems Analyst to join our global IT team. This role is responsible for bridging the gap between business needs and technical solutions, · ensuring that systems, processes and data deliver maximum value to the organization.Collaborate with business ...

    Pune

    2 weeks ago

  • Work in company

    Security/System Analyst

    Only for registered members

    The job of Security/System Analyst is to serve as technical expert in cybersecurity matters. · ...

    Pune, Maharashtra

    1 month ago

  • Work in company

    Specialist : Systems Analyst

    Only for registered members

    We are seeking an experienced TMS Analyst with strong knowledge of Warehouse Management Systems (WMS), Transportation Management Systems (TMS), and related logistics processes. · This role will act as the bridge between WMS functional teams and TMS teams/vendors, ensuring that a ...

    Pune

    2 weeks ago

  • Work in company

    Accounting Systems Analyst

    Only for registered members

    The Accounting Systems Analyst supports the Accounting Information Systems Administrator by assisting in the administration maintenance and continuous improvement of Workday and other Accounting Information Systems This role helps optimize system functionality collaborate with co ...

    Pune

    1 week ago

  • Work in company

    DAP System Analyst

    Only for registered members

    DAP System Analyst is responsible for overseeing end-to-end project lifecycle including proposing and implementing new technologies aligned with organizational strategy. · ...

    Pune OTHER

    4 weeks ago

  • Work in company

    IT Business Systems Analyst

    Only for registered members

    At Zendesk our IT team in partnership with business stakeholders is dedicated to enhancing finance operations and technology As we expand our team in Pune we are looking for a skilled Business Systems Analyst with experience in Netsuite Core finance R2R and S2P processes · ...

    India - Pune

    1 day ago

  • Work in company

    Business Systems Analyst

    Only for registered members

    We are seeking a Business Systems Analyst to join our global IT team. This employee will work with senior leadership and end users to design and deliver solutions aligned with major strategic initiatives. · Collaborate with business stakeholders to gather, analyze, and document d ...

    Pune, Maharashtra

    2 weeks ago

  • Work in company

    DAP System Analyst

    Only for registered members

    DAP System Analyst responsible for overseeing end-to-end project lifecycle and proposing new technologies aligned with organizational strategy. · ...

    Pune

    1 week ago

  • Work in company

    System Analyst-EDI

    Only for registered members

    Eaton's Corporate IT team is seeking a System Analyst – EDI to join our EDI team. · ...

    Pune Full time

    1 month ago

  • Work in company

    Business Systems Analyst

    Only for registered members

    The Business Systems Analyst (BSA) – IT Infrastructure will work on contract and act as a key liaison between business stakeholders and IT infrastructure teams. · Gather, analyze, and document business requirements related to IT infrastructure services. · ...

    Pune, Maharashtra, India

    4 days ago

  • Work in company

    Business System Analyst

    Only for registered members

    Analyze business needs, reengineer business processes for greater efficiency, and translate business requirements into detailed system specifications. · Collaborate with technology teams on solution design and guide hardware/software/vendor selection · Conduct end-to-end testing ...

    Pune, Maharashtra

    4 weeks ago

  • Work in company

    IT Business Systems Analyst

    Only for registered members

    The Oracle Business Systems Analyst will take direction from the Oracle Business Systems Manager/Lead in support of Oracle Projects related production issues and participate in rollout/implementation of selected Oracle modules. · The job includes identifying user requirements, wr ...

    Pune

    1 month ago

  • Work in company

    System Analyst-EDI

    Only for registered members

    Eaton's Corporate IT team is seeking a System Analyst – EDI to join our EDI team. This role is pivotal in driving enterprise digitization and supporting our global B2B EDI customers across the Americas, EMEA, and APAC regions. · ...

    Pune, Maharashtra

    1 month ago

  • Work in company

    Business System Analyst

    Only for registered members

    Rockwell Automation is a global technology leader focused on helping the world's manufacturers be more productive, sustainable and agile. · ...

    Pune, Maharashtra

    6 days ago

  • Work in company

    DAP System Analyst

    Only for registered members

    The DAP System Analyst position involves overseeing end-to-end project lifecycle, proposing and implementing new technologies aligned with organizational strategy. · ...

    Pune, Maharashtra

    4 weeks ago

  • Work in company

    Business Systems Analyst

    Only for registered members

    The Red Hat Training and Certification Global Delivery Team is seeking a Business Systems Analyst to drive insights and strategy through data analysis. · ...

    Pune, Maharashtra

    2 weeks ago

Jobs
>
Pune