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Alimentiv

Posted 3 months ago

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Clinical Project Manager (US)

RaleighRemoteFull-time

AI Summary

Manages planning, execution and completion of clinical research projects, coordinating cross-functional teams to ensure regulatory compliance, data management, and timely project delivery throughout the life cycle.

About this role

Project Management

  • Manage the planning, execution, progress and completion of assigned clinical research projects.
  • Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies.
  • Maintain operational, financial and regulatory integrity and safety.
  • Develop and/or participate in the development of project communications, training, regulatory submissions and/or audits and selection of third party vendors as required.

    • Documents and Tools

  • Manage a cross-functional team to ensure the appropriate creation, delivery, maintenance and disposal of all related data, documents, equipment and tools, including protocols, SOPs, informed consent forms, case report forms and instructions.
  • Prepare investigator updates and other project related reports as required to support the proper conduct and execution throughout the life cycle of assigned projects.

    • Project Team Performance

  • Identify, assign and monitor the completion of interdisciplinary project tasks that include site monitoring, CRF and database development and revision, data collection, patient safety/adverse event management, document management, statistical analysis and/or final report writing and publications.
  • Ensure task completion performance meets or exceeds quality standards and sponsor/client, project and regulatory expectations and guidelines.

    • Client/Sponsor Support

  • Act as primary liaison throughout the project life cycle ensuring client/sponsor expectations are appropriately managed by addressing and resolving queries/issues, planning and executing all project meetings, assisting with site and patient recruitment strategies and materials, assisting with the development of stakeholder training and by regularly providing sponsor/client with project status and update reports.

    • Qualifications

  • Applicants should have a minimum of a Bachelor's Degree in a relevant field of study (Health Sciences, Clinical Research preferred) and 1-3 years of experience in clinical study management
  • The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results.
  • Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.
  • Ability to engage in continuous learning and self-development.
  • Ability to continually foster teamwork.
  • Fluent in reading, writing, and speaking of English

    • Working Conditions

  • Home Based
  • Occasional travel

    • Skills

    Adverse Event ManagementBudget And Vendor NegotiationCAPA And Quality AssuranceClinical Project ManagementCRF Design And Database DevelopmentDocumentation ControlGCP (Good Clinical Practice)Informed Consent ProcessesProject CommunicationsRegulatory Audits PreparednessRegulatory SubmissionsRisk ManagementSite MonitoringSponsor/vendor ManagementStatistical Analysis CoordinationTrial Governance

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