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Study Manager

Study Manager

inSync StaffingNovato, CA, US
15 hours ago
Job type
  • Full-time
Job description

Job Description

Sr. Study Specialist

Hybrid - 2 days per week onsite in Novato

1 year contract

Pay Range : $65.00 - $69.00

The Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.

Role Summary

The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and / or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies :

Core Competencies :

  • .Agility and Proactivity
  • .Leadership
  • .Communication and Collaboration

Technical Competencies :

  • .Study Management and Execution
  • .Compliance and Quality
  • .Drug Development and Study Design
  • .Product and Therapeutic Area Knowledge

    • Responsibilities include but are not limited to :

  • .Develop study specific documentation, as delegated by the Study Manager
  • .Contribute to the oversight of country and site feasibility assessment and site selection.
  • .Oversight of CRO for IRB / EC related submission / approval activities
  • .Oversight of essential documents for study life-cycle management
  • .Develop / Oversee site and investigator training materials
  • .Present at investigator meetings as assigned
  • .Ensure accurate and timely study entry and updates to ClinicalTrials.gov
  • .Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
  • .Process documents for signature in DocuSign
  • .Oversight of Clinical Trial Insurance
  • .Attend Global Study Operations team, vendor, and / or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
  • .Oversee and manage essential documents in the Trial Master File (TMF)
  • .Contribute to Global Study Operations risks identification and mitigations.
  • .Provide support and administrative assistance with internal and external meetings

    • Education & Experience

  • BA / BS or higher in nursing, life or health sciences is preferred.. Industry or relevant experience in lieu of education is considered.
  • Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets,

    • Benefits (employee contribution) :

    Health insurance

    Health savings account

    Dental insurance

    Vision insurance

    Flexible spending accounts

    Life insurance

    Retirement plan

    All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants : Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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    Study Manager • Novato, CA, US