ANALYST I GLOBAL DATA MANAGER
Descripción de la oferta de empleo
The Analyst Data Manager is a professional individual contributor role at entry level that provides oversight and accountability and/or executes data management activities and/or performs scientific data review for one or more trials of low to moderate complexity.
The Analyst Data Manager makes recommendations and influences decisions for specific trials or assignments.
This position analyzes and provides input into decisions with direction from manager or Data Management Leader (DML).
This position receives ongoing direction to achieve objectives, and work is reviewed on a regular basis with the Data Management Leader.
Principal Responsibilities.
Work with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations to the business for assigned trial(s) to include but not limited to.
o Gather and/or review content and integration requirements for eCRF and other data collection tools.
o Participate in establishing conventions and quality expectations for clinical data.
o Participate in establishing expectations for dataset content and structure.
o Work with others to set timelines and follow-up regularly to monitor delivery of all data management milestones.
Review clinical data management documents (including submission package) for appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
Work with DML to facilitate compliance with regulatory guidelines and the documentation matrix.
Work with DML to facilitate real-time inspection readiness of all assigned deliverables for the trial.
Participate in regulatory agency inspections and J&J internal audits as necessary.
Work with DML to plan and track content, format, quality, and timing of applicable data management deliverables.
Work with DML to ensure deliverables are on time.
Support the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are met.
Identify and communicate lessons learned with support from DML and frequently asked questions at trial level.
Contribute to the creation of key functional plans (e.
.
study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
Participate in process, system, and tool improvement initiatives.
This position may be specialized into the following roles based on business needs.
Global Data Manager (GDM), Clinical Data Manager (CDM) Global Data Manager role-specific responsibilities.
Perform trial level oversight controls and/or execute data management activities per applicable procedures, with DML direction.
Clinical Data Manager role-specific responsibilities.
Support (complex) scientific study data review and management of CDM, Study Responsible Scientist (SRS, and Study Responsible Physician related queries in EDC system.
Involvement in other clinical data review activities (e.
., Coding, SAE reconciliation) is possible.
Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.
Principal Relationships.
Reports into people manager position within functional area (e.
., Data Management Leader).
Functional contacts within IDAR include but not limited to.
Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations.
Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but not limited to.
Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources and Project Coordinators.
External contacts include but not limited to.
External partners and suppliers, CRO management and vendor liaisons, industry peers and working groups.
Qualifications Education and Experience Requirements.
Required Bachelor's degree (e.
., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences.
Ability to communicate effectively in English (written and verbal).
Preferred Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols.
Experience in clinical drug development within the pharmaceutical or related industry.
Knowledge of applicable international guidelines regarding data management of clinical trials.
Knowledge of current industry standards (e.
., CDISC, SDTM, CDASH, etc.).
Knowledge of technology platforms for data exchange and project management.
Other.
Approx.
Detalles de la oferta
- Sin especificar
- En toda España
- Sin especificar - Sin especificar
- 05/11/2024
- 03/02/2025
Somos una firma global de consultoría de comunicación, asuntos públicos y marketing digital... parte de tus funciones serán: desarrollo e implementación de políticas de datos seguridad y cumplimiento datos maestros y metadatos gestión de calidad de datos evaluación y mitigación de riesgos formación......
Solid knowledge of data structures and experience with integration of data from multiple sources... ensures that non-functional/support aspects of data classification and data sharing agreements (dsas) and sign-offs are fulfilled... leads and coordinates data acquisition from both internal and external......
Diplomatura o enginyeria tècnicadiplomatura o enginyeria tècnica - administració i direcció d'empreses-ciències empresarialsespanyol (parlat c2 - d... detall de les funcions del lloc de feina• lead projects related commercial excellence • supports the sales team, analyzing complex data base, obtaining......
Experience of working on large requirements i... join our growing team as a key account manager in the gbs team, you will focus on growing and developing existing clients, as well as generating new business by identifying, implementing and executing new strategies... as a global aggregator providing......
Our division focuses on gathering, enriching and processing data for machine learning in different ai domains... we offer high-quality data for human-machine interaction to some of the most prestigious technology companies in the world... position: data contributor project location: barcelona, spain......
Requisitos del puesto completion of a master’s degree/mba or an equivalent qualification is required, coupled with practical work experience, preferably in hr tech, within roles such as customer success manager, account manager, or delivery manager... active participation in management meetings is essential......
Img arena is looking for sports fans in spain to collect live data from basketball games... this position is not remote, so your presence at the venue would be required to ensure accurate and timely data collection... benefits 45€ for each event covered freelancer agreement for 1 year with the possibility......
Se precisa para incorporación inmediata vigilantes con tip, para la zona de bages i baix llobregat... jornada completa, disponibilidad para trabajar fines de semana i festivos, permiso de conducir y vehículo propio, incorporación inmediata... formación a cargo de la empresa......
• content management and creation for opentop social networks, opentop web site, press releases, etc, acting as community and communications manager of opentop... • manage the relationships with the different stakeholders of the innovation ecosystem, with focus on startups, entrepreneurs, vcs and accelerators......
Descripción:empresa española de terapias alternativas y astrologia precisa incorporar una community manager para su proyecto en madrid... se busca persona adaptable, constante y dinámica con posibilidad de continuidad en la empresa e incentivos por objetivos preferiblemente freelance (no obligatorio)......