Case Manager

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Case Manager 

Brisbane, CA
6 month contract - possibility to extend or convert

Job Description:

Seeking a driven, compassionate and innovative Case Manager (CM) for the global Early Access (EA) and Investigator Sponsored Trial (IST) programs in the Global Medical Affairs department. This role is vital to achieving program goals and offers an opportunity to work on a variety of projects that reflect the company’s patient focused mission.
The CM is responsible for the day-to-day management and operations of expanded access clinical trials, ISTs and EA (“Compassionate Use”) cases including the management of vendors, clinical monitors and participating IST and EA sites. This position will also work closely with cross-functional teams to ensure that these programs are conducted in a timely fashion and in a manner compliant with ICH/Good Clinical Practice (GCP)/regulatory guidelines and SOPs as well as company goals and budgets.
Responsibilities including, but not limited to:

  • Manages the operational aspects of expanded access clinical trials, Investigator Sponsored Trials (ISTs), Early Access (“Compassionate Use”) cases and Sponsored Research
  • Participates in protocol, informed consent, CRF development, Clinical Study Report preparation, NDA submission, as appropriate
  • Prepares metrics and updates for management, as assigned
  • Manages case/study timelines and budgets
  • Proactively identifies potential issues/risks and recommends/implements solutions
  • Participates in and facilitates CRO/vendor selection process for outsourced activities
  • Manages CRO/vendor interactions, providing sponsor oversight of operational activities (e.g., case management, monitoring, project master files), develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
  • Prepares and/or reviews/approves case-related documents/templates, as appropriate (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines), and site-related documents (informed consent template and tools/worksheets), investigator contracts, and site payments
  • Manages case monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regional/country specific regulations
  • Recommends and implements innovative process ideas to impact early access clinical trials management
  • Organizes and manages internal cross-functional review meetings, team meetings, investigator meetings and other case-specific meetings, as required
 Technical Requirements & Skills:
  • Serves as an internal liaison and resource for Investigators/Physicians and Medical Science Liaisons (MSLs)
  • Participates in the selection, training and evaluation of department personnel (contract and internal) to ensure the efficient operation of the function, and may manage and mentor staff
  • Participates in the development, review and implementation of departmental SOPs, processes, templates and tools
  • Bachelor’s degree or relevant experience required
  • Experience in rare diseases is a plus, but not required
  • Willingness to address urgent treatment requests when needed5+ years of relevant industry experience, with at least 3 years of direct clinical trial management experience at a Sponsor/Company or CRO
  • Proven ability to provide functional expertise to a clinical development program in a specified product area with experience in managing CROs, specialty labs, outside vendors and international trials
  • Late Phase or Phase IV experience a plus, but not required
  • Familiar with advanced concepts of clinical research with demonstrated knowledge of clinical research operations, including interpretation and implementation of FDA and Country regulations/ICH guidelines, is required
  • Must possess a high degree of customer focus towards internal and external stakeholders; strong collaboration skills, excellent planning skills and able to manage multiple projects with time demands
  • Problem solver and effectively works in a team environment
  • Highly effective verbal and written communication skills required
  • Minimal travel may be required

Job Details

Job Type: Contract
Location: Brisbane, CA
Job ID: 19-09808
Date Updated: November 8, 2019