Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
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Direct experience authoring or reviewing clinical study reports, protocol synopses, or regulatory dossier modules for a pharmaceutical, biotech, or CRO organization
Deep familiarity with ICH-GCP standards, FDA/EMA regulatory expectations, and the scientific rigor required in investigator brochures and medical affairs materials
Expert-level document, spreadsheet, and slide craftsmanship, with excellent written communication and attention to detail
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
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RequirementsDegree in Architectural, Civil or Structural EngineeringMinimum 2 years of working experience in the construction (preferable in cable) industry
Key Responsibilities:• Administers project team for fibre installation for non-residential/commercial building coordinates with client, building management and customers for site survey• Able to purchase plan route maps and apply Notice of Commencement Earthworks applications for all necessary utilities such as Cable, Gas, Telco, PUB, SCDF, etc• Finalization of claim submission of the work done cable work claims for Trial Hole, Cable pulling, Pipelaying and Joint/Termination Claims to Power Grid NOVA system• Monitor and update the list of work done claims to update the master list for work status• Able to report work and claim status to Project Engineers and Project Managers• Handle complex designing and drafting assignments under minimal supervision• Create drawings and models from written and verbal specifications obtained from Project Engineer• Work with Engineers regarding model accuracy, design, drafting standards and design documentation• Work closely with Designers, Drafters and Engineers to ensure coordination design effort is maintained• Review drawings for completeness and accuracy• Maintain all revisions of project drawings• Update and maintain drawing log• Develop 3D models by analyzing prototypes and 2D drawings• Examine and check engineering drawings for compliance with cited specifications• Provide timely technical assistance and solutions to the team• Participate in project meetings and conference calls as required
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As part of our global team, you'll have the opportunity to perform and coordinate different aspects of the clinical monitoring and site management process. As a Clinical Research Associate I, you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
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