Project Manager - Clinical Research
CPC Clinical Research - Aurora, CO

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CPC Clinical Research is an academic led Contract Research Organization dedicated to the management of clinical trials with the highest levels of quality and integrity. Competitive salary and benefits package, flexible schedules, and on-site exercise facilities.

Job Title: Project Manager – Clinical Research

Responsibilities:

  • Serve as the primary point of contact for industry sponsored clinical trials.
  • Develop and manage multidisciplinary project team members. Schedule, plan for, and minute regularly scheduled project team meetings. Assess project issues, propose resolutions to the project team, CPC executives and/or the Sponsor, and then track implementation of resolution through to completion.
  • Define and monitor project scope, timelines and deliverables from project initiation to close out. Assist in study site selection, initiation and monitoring as required by project. Provide drug tracking and disposition as needed as required by project.
  • Develop and manage site and vendor contracts.
  • Ensure the overall quality of project services and deliverables.
  • Assure qualifications and accurate study regulatory documents for new sites and work with RA/QA on approval for investigational product release.
  • Participate in the design, writing and review of all project-related documents including: budgets and proposals, change orders, and study content documents including protocols, case report forms, statistical analysis plans, study reports and monitoring documents.
  • Provide status reports on all projects as necessary.
  • Assist in IRB issues.
  • Track and request study site and vendor payments.
  • Provide necessary updates and reports to the Sponsor as outlined by the contract.
  • Supervise trial related activities and provide performance feedback to supervisors for all project team members.
  • Manage and conduct CPC Core Lab activities as deemed necessary.
  • Oversee SAE process and assure execution of the SAE Plan.
  • Identify vendors and manage vendor services.
  • Conduct site monitoring visits as needed.
  • Additional duties as required.

Qualifications:

  • A minimum of a BA/BS in a scientific field with a minimum of 5 years experience in medical research or related field and a minimum of 2 years clinical research project management experience.
  • Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
  • Medical device experience preferred.
  • Experience with MS Office including Access, Word and Excel.
  • Excellent interpersonal communication skills, organizational skills and a great attention to detail are required. This individual must be able to work as a member of a team and possess good problem solving skills.
  • Possess the ability to organize, instruct and supervise staff, while promoting group effort and achievement.
  • Ability to manage conflicts and resolve problems effectively.
  • Ability and willingness to travel up to 25%.

Send cover letter, CV and 3 references.


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