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Clinical Trial Manager

Green Key Resources Brisbane, CA
  • Posted: over a month ago
  • Contractor
  • Benefits: Vision, Medical, Life Insurance, 401k, Dental

The Clinical Trial Manager is accountable for the day-to-day operational oversight of one or more clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity typically is coordinated in conjunction with one or more CROs. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

Essential Duties & Responsibilities

  • Manages the operational aspects of clinical trials
  • Participates in protocol review, CRF development, Clinical Study Report preparation, NDA submission, as appropriate
  • Prepares metrics and updates for management, as assigned
  • Proactively identifies potential study issues/risks and recommends/implements solutions
  • Participates in and facilitates CRO/vendor selection process for outsourced activities
  • Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
  • Manages vendors for clinical trial execution (e.g. IWRS, Central Lab, ePRO, etc)
  • May work with CRO and other vendors to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
  • Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)

Green Key Resources

Premier executive recruitment firm specializing in permanent placement, contract consulting, temp-to-hire and temporary staffing within the following specialty areas: accounting-finance, healthcare nursing & allied health, pharmaceutical, financial service operations, information technology, creative, hospitality, office/legal support and human resources across our offices nationwide. Our recruiters are highly-specialized consultants who only recruit within specific job disciplines. Each of our division leaders has over a decade of direct experience working in the industries they serve. The bottom line is that we understand your business, your challenges – and most importantly what it takes to source and successfully hire top talent. When you’re looking to hire people who make an immediate impact, unlock your potential with Green Key Resources.

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