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    Senior Project Clinical Data Manager - London, United Kingdom - Empatico Consulting

    Empatico Consulting
    Empatico Consulting London, United Kingdom

    8 hours ago

    Default job background
    Pharmaceutical / Bio-tech
    Description
    Senior Project Clinical Data Manager

    We have the pleasure of working with a fantastic early phase CRO based in London. The company have a strong leadership team who are accelerating growth and have a great vision for the future. The offices are very modern and they have a fully kitted out clinical site close by. They take an encouraging attitude towards management, autonomy, work/life balance, inclusivity and have a great culture. They are very team orientated, projects are collaborative and it really is a very positive place to work


    Due to their growth, they are now looking for a Senior Project Clinical Data Manager to join their Data Management team.

    You will act as the primary Data Management Lead for assigned projects, take responsibility for resourcing and planning and carry out leadership and management of projects and clinical trial data from design of the study through to final delivery of clinical datasets.


    Providing SAS programming support through all phases of the projects along with detailed knowledge of CDISC with experience of mapping and programming SDTM standard datasets is essential.


    This is a hybrid role and will initially require more office presence, gradually transitioning to a flexible schedule, possibly one day per week.


    Role Overview:


    Provide leadership and where required, management of Project Data Managers and other staff, in addition to leadership and management of projects and clinical trial data from design of the study through to final delivery of clinical datasets.


    Act as the primary Data Management Lead for assigned projects ensuring clinical projects are carried out by the company in accordance with the executed contract, ICH GCP and other relevant regulations and guidelines and the customer's expectations, taking responsibility for resourcing and planning of assigned projects.


    Provide hands on technical data management expertise and SAS programming support through all phases of the projects following industry standards (CDISC), from database build through to delivery of mapped datasets.

    Support projects from both the Clinical Site data perspective, as well as the Data Management vendor side.

    Key areas of responsibility

    Functional Lead for Site Source Data Management or Vendor Data Management on assigned projects
    Delivery and completion of all data management according to contractual agreement, relevant SOPs, guidelines and regulations
    Responsible for scope, budget, revenue recognitions for data management aspects of projects and provide support to junior staff on their projects
    Resource management for assigned projects
    Creation, review and approval of all Data Management associated documentation
    eCRF/eSource database and Edit checks design, build and validation
    Programming of off-line validations and database mapping using SAS
    Query management, Coding, SAE and third party data reconciliation
    Responsible for driving the oversight and management of the database lock process in accordance with the study plans, including data review meeting preparation and participation, data review report writing/validation, and Data Management Report writing
    Primary point of contact for specified external data vendors
    Oversee the setup/design of study specific paper source and/or e-Source database and associated documentation
    Provide project/system specific training for CRAs and site staff as required
    Manage and oversee Quality Control (QC) process checks for eCRF database versus paper source / e-source
    Manage and oversee scheduled data transfers/imports/exports to/from eSource/eCRF database and associated systems
    Participate in and present at internal, customer, third-party, and investigator meetings or seminars
    Development of departmental strategies, technologies, SOPs and process
    Develop and delivery of applicable data management training
    Support departmental management by training, developing and mentoring of data management staff
    Maintain proficiency in Data Management systems and processes
    Network with colleagues for new and/or repeat business
    Support departmental management by driving the development of Data Management tracking systems, databases and reporting systems to support business requirements
    Develop and report on Data Management key performance indicators
    Contribute to the maintenance of data capture standards library


    Duties include:
    Liaise with Project Management and other functional groups
    Oversee and manage all Data Management processes
    Provide regular monitoring and communication of project progress
    Participate in project reviews and lessons learned by providing and presenting input from the data management area
    Monitor data workflow using enrolment, data collection/cleaning metrics
    Ensure documents and databases (data sets) are archived and/or returned to the customer appropriately at the end of each study
    Coordinate, define and implement user testing to a high standard for data entry screens, electronic edit checks, data listings, import/export programs and medical coding (e-source and eCRF systems)
    Provide support with the definition, identification and minimisation/prevention of Protocol Deviations and the associated process
    Schedule and request data transfers/imports/exports to/from eCRF/eSource database and associated databases

    Creation, Peer review and approval of:
    project plans and guidelines for data validation, electronic data interchange, coding, paper source/e-Source, eCRF screen creation, database design, user testing, source and eCRF tracking and completion, and other applicable project plans as delegated/required;
    specifications for listings and summaries from eSource/eCRF databases, and external data sources
    output from listings and summaries from e-Source/eCRF databases, and external data sources
    Participate and present at internal, customer, third-party, and investigator meetings

    • Oversee preparation and attend sponsor/regulatory audits as required
    Actively identifies and participates in the development of departmental technologies, SOPs, processes, and procedures
    Contribute to the Request for Proposal (RFP) and Request for Information (RFI) process. Prepare input and participate in bid defence meetings

    Essential

    Degree or equivalent
    Knowledge of current regulatory regulations, GCP, ICH guidelines and Data-management industry standards
    SAS programming
    Detailed experience of end to end Clinical trial and Project Data Management processes, as well as extensive experience in the Data Management industry
    Detailed knowledge of CDISC with experience mapping and programming SDTM standard datasets
    Flexible and adaptive approach, being able to rapidly re-prioritise whilst maintaining a clear vision, as well as work effectively with various situations or individuals

    #clinicalresearch #earlyphase #earlyphaseCRO #growth #motivation #clinicaldatamanagement #clinicaldatamanager #SASProgramming #SDTM #growingCRO #CROopportunities
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