Clinical Study Manager in San Diego, CA at Volt

Date Posted: 5/6/2020

Job Snapshot

  • Employee Type:
    Direct Hire
  • Location:
    San Diego, CA
  • Job Type:
  • Duration:
    N/A
  • Date Posted:
    5/6/2020
  • Job ID:
    228730
  • Contact Name
    Volt Branch
  • Phone
    805/426-6732

Job Description

Volt Workforce Solutions has an excellent opportunity for a Clinical Study Manager in San Diego, CA.  This position is with a cutting-edge company in clinical-stage biotechnology developing first-in-class immunology. This position is accountable for all operational activities related to planning, executing/conducting and reporting out of assigned clinical study in support with product development portfolio. The CSM will independently organize and manage multiple activities related to clinical studies, while simultaneously ensuring study milestones are met and studies are completed in accordance with the protocol and ICH/GCP requirements. Duties involve contributions to multiple clinical studies of differing phases, project planning, budgeting, participating in the selection of clinical sites, selection and management of clinical vendors, organizing and conducting Investigator Meetings, making clinical presentations, etc. The successful candidate drives the conduct of the study, maintains study level reporting systems, progress reports and trackers to ensure all study operational aspects are on track in support of the company’s clinical programs. 

Essential Functions

  • Effectively manage multiple studies and/or programs simultaneously to ensure time, quality, and cost metrics are adequately defined and met. Identify and manage potential risks and impacts with regard to:
    • Site identification/qualification
    • Site start-up and initiation (e.g., CTAs, Study budgets, Enrollment/Retention Plans, Monitoring Plans)
    • Study conduct
    • Data collection, management, and analysis
    • Final data/reporting
  • Effectively collaborate with the operational project team members and stakeholders from CMC, Finance, Legal and Regulatory Affairs as necessary regarding performance (KPIs) related to clinical study vendor(s) ensuring compliance with study specifications (i.e., timelines, deliverables, budgets) and applicable SOPs
  • Execute study management with thorough understanding of the drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA) and applies this knowledge to all aspects of the study (startup through conduct to closeout)
  • Participate in study center selection, pre-study qualification, initiation, and closeout.
  • Coordinates and conducts study monitoring with CRAs to ensure study compliance, data quality, proper documentation and study completion
  • Oversees plans and preparation for/of Essential Documents (e.g., Patient Informed Consent Forms, 1572s,)
  • Identify, manage and supervise clinical CRO and consultant activities.
  • Negotiate clinical trial agreements and budgets; manage the budget and vendor site payments.
  • Participate in developing study-related documents such as protocols, SOPs, work instruction documents, informed consent forms, and case report forms (CRFs), etc.
  • Participate in the preparation and writing of Investigator’s Brochures and clinical sections of regulatory documents such INDs, DSURs, NDAs, etc. (and/or international equivalents).
  • Participate and support publications based on the clinical program.
  • Communicate with cross-functional colleagues (Regulatory, QA, CMC, Finance, etc.) to ensure all stakeholders are informed of and aligned with clinical activities.