Clinical Operations Manager II

4 days ago

Aurora, Colorado, United States CPC Clinical Research Full time
Job Description

Job Summary:

CPC Clinical Research is seeking an experienced Clinical Operations Manager II to oversee clinical operations management activities, define and monitor project scope, timelines, and deliverables, and provide expert advice in the design, writing, and/or review of all project-related essential documents.

Key Responsibilities:

  • Project Management: Oversee clinical operations management activities, define and monitor project scope, timelines, and deliverables from project initiation to close-out.
  • Team Management: Identify project-specific training for team members and notify appropriate designees to ensure completion and filing of training documentation.
  • Vendor Management: Track and approve vendor payments.
  • Document Management: Provide expert advice in the design, writing, and/or review of all project-related essential documents, including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, essential documents, monitoring plans, and report templates.
  • Team Leadership: Develop and manage multidisciplinary project team members, organize, plan for, and produce minutes for project team meetings.
  • Quality Assurance: Ensure the overall quality of project services and deliverables.
  • Communication: Provide necessary updates and reports to the sponsor as outlined by the contract.
  • Event Planning: Plan and oversee the execution of investigator meetings as contracted.
  • Business Development: Work with the Business Development team on budgets, proposals, and change orders.
  • Regulatory Compliance: Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact.
  • Document Control: Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper.
  • Regulatory Knowledge: Adhere to local, federal, and international regulations, guidelines, and CPC Policies, Standard Operating Procedures (SOPs), and Work Instructions (WIs).
  • Endpoint and Specialty Services: Define and monitor Endpoint and Specialty Services scope, timelines, and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.
  • Committee Management: Manage contracted deliverables for external committees, including but not limited to meeting scheduling, generation of meeting minutes, and distribution of meeting materials.
  • Safety Management: Oversee SAE process and assure execution of safety plans.
  • Data Management: Accurately track receipt, entry, upload, and the processing of photos, acetate tracings, and other source documents submitted from sites.
  • Communication: Contact appropriate individuals regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.
  • Data Entry: Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required.
  • Feedback: Provide feedback to study sites on tracing and quality issues, as required by project.
  • Core Lab Activities: Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.
  • Biostatistics and Programming Support: Provide operational support for the biostatistics and programming deliverables.

Requirements:

  • Education: Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).
  • Experience: 4 years of experience in a clinical research setting, preferably with at least 2 years of project/operations management experience in clinical research.
  • Skills: Demonstrated ability to adequately manage all facets of a clinical trial with minimal direction, thorough knowledge of the Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials, proficiency in Microsoft Office, particularly Outlook, Word, and Excel, excellent communication and organizational skills, great attention to detail, and exemplary skills leading and managing multi-disciplinary teams in a clinical research setting.
  • Travel: Willingness to travel 20-25%.

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