Project Manager- Pharmaceuticals- Remote

Company: Jobot
Location: Las Vegas
Posted on: June 24, 2022

Job Description:

100% paid health benefits/ PTO/ Stock Options/ 401k MatchThis Jobot Job is hosted by Juan CorreaAre you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.Salary $140,000 - $180,000 per yearA Bit About UsWe are a developer of generic and specialty drugs for treatment of diseases related to digestive, endocrine, musculoskeletal and urinary system. We also conduct research for developing drugs in the therapeutic areas of autoimmune, eye diseases and immuno oncology indications.Why join us?

• Professional Development
• Medical Benefits (Medical, Dental, Vision, 401K Plan)
• Holidays
• Vacation
• Life InsuranceJob Details
  • Manages clinical projects from concept through clinical study report completion in line with company, Good Clinical Practice, regulatory, standards, and compliance requirements.
  • Achieves study objectives by developing project priorities, setting milestones, and resolving project conflicts.
  • Assesses the operational feasibility of studies and recommends execution and risk mitigation plans.
  • Prepares study-related documents, including protocols, protocol amendments, informed consent forms, patient questionnaires, monitoring plans, trial master files, case report forms and other study tools.
  • Prepares IRB submissions and address IRB questions.
  • Develops, track, and manages study timelines, budget, and study metrics.
  • Works with legal team to facilitate the preparation of clinical trial agreements, non-disclosure agreements, consultant agreements, vendor agreements and other contracts.
  • Ensures appropriate clinical resources are available for the clinical project.
  • Leads investigator/site staff meetings and site trainings.
  • Manages clinical research study conduct and ensure it is in compliance with GCP and regulatory requirements.
  • Participates in CRO, consultant and other vendor selection, negotiation, and management of the contract, including monitoring of associated budgets and payment of invoices.
  • Select study investigators, screening sites and evaluate adequacy to perform research and meet study timelines.
  • Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants.
  • Ongoing analysis of study enrollment to ensure goals are on target.
  • Participates in the analysis, summary, and reporting of clinical data through the course of the study.QualificationsEducational Requirements
    • BS/MS in Chemistry, Biology, Biochemistry, business, or related healthcare area
    • Preferred PMP or CAPM or similar project management certificationRequired Experience And Skills
      • Work experience minimum of 5 years
      • Project management experience and training in a relevant industry or academic setting (clinical research) minimum of 3 years
      • Sound knowledge of drug development and understanding of FDA and ICH GCP guidelines
      • Proven problem solving and project management skills
      • Excellent verbal and written communications skills
      • Excellent stakeholder and customer relationship management
      • Ability to collaborate across functional areas and geographic boundariesPreferred Additional Experience And Skills
        • Relevant pharmaceutical experience
        • Experience in Project Management covering all phases of project execution
        • Proficiency with advanced collaboration and task-centric tools (e.g. Microsoft Sharepoint, OneDrive, and Box, etc.)
        • Proficiency with Microsoft Word, Excel, PowerPoint, Project (or related tools) and capable of maintaining appropriate project documentation
        • Agile mindset to adapt to evolving needs internally as well as externally
        • Flexible working in a dynamic global environment
        • Member of professional organizationInterested in hearing more? Easy Apply now by clicking the "Apply" button.

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