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Clinical Operations Associate Jobs

Company

SSi People
Address United States
Employment type CONTRACTOR
Salary
Expires 2023-07-08
Posted at 10 months ago
Job Description
  • Development of program specific standards (e.g., agendas, minutes, filing structure, team materials)
  • Trial Master File and Essential Documents management
  • Assist with management of clinical systems updates, enhancements and master data stewardship as required
  • Clinical Inspection Readiness and Quality Management System activities (e.g., deviations and CAPAs)
  • Participate in the development, review, implementation and updating of key standard processes that lead to positive and measurable impact for clinical programs managed by the clinical management team (e.g., quality, efficiency, consistency)
  • The Clinical Operations Associate tasks include:Responsible for execution of assigned clinical operations activities in support of study conduct throughout the study lifecycle and will ensure quality execution and compliance with all required policies and procedures in completion of assigned tasks. This individual will work closely with clinical operations management to ensure adherence to applicable metrics associated with assigned tasks completion.
  • Support clinical operations aspects of Client's clinical trials conduct as assigned including but not limited to:
  • Support with tracking and reporting of Key Performance Indicators (KPIs) and metrics for quality oversight of applicable clinical operations related activities as assigned
  • Project coordination activities
  • Resource acquisition & allocation activities
  • Maintenance, quality control, distribution, and archiving of clinical trial documents and reports
  • Meeting, events, and training logistics and planning
  • Contracting and invoicing of key advisors/vendors/external service providers (ESPs)
  • Clinical audit/inspection activities as assigned
  • Creation and maintenance of databases or tracking tools
  • Perform other duties as assigned
  • Serve as a resource to departmental personnel and external service providers in areas of expertise including applicable internal database and electronic systems applications (e.g., EDMS, CTMS, eTMF, legal databases, QMS, etc.) and process management (e.g., contracting, document management, etc.)
  • Support coordination of project activities and liaise between global affiliates, external vendors, and clinical research teams as requested
  • Assists with the management of ESP counterparts and processes for vendors / external service providers / contract personnel implementing program level activities specific to assigned job responsibilities (e.g., meeting coordination, advisor contracting, OST training, etc.)
  • Collaborate/Interact with internal and external stakeholders as related to conduct of required job responsibilities


  • Preferred: Bachelor’s Degree
  • Qualifications/Experience:Required: High school graduate; associated training/certification(s); 7 to 10 years related experience


  • Comfortable in a fast-paced environment and able to adjust workload based on changing priorities
  • Required Skills Include:Experience with PC-Windows, word processing, and electronic spreadsheets required
  • Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)
  • Ability to work effectively within a team matrix as well as independently
  • Ability to collaborate and respond to changing circumstances and needs
  • Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors, and consultants
  • Clinical trials support or pharmaceutical industry experience required
  • Knowledge of ICH/GCP, local regulatory authority drug research and development regulations and clinical trial operations required
  • Demonstrated strengths in planning, organizational skills, analytical skills, time management, conflict management, problem solving, and attention to detail
  • Ability to travel as required to carry out responsibilities