Global Studies Leader in New York, NY at Apex Life Sciences

Date Posted: 5/8/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    New York, NY
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    5/8/2018
  • Job ID:
    845183

Job Description


Duties:

  • Main Responsibilities and Accountabilities Accountable for efficient delivery of clinical studies through all phases and stages in accordance with appropriate quality standards including ICH/GCP and applicable regulations.
  • Provides direction and leadership to SMTs to ensure delivery of all cross functional activities in line with the clinical development plan
  • Creating and managing study timelines, budget, resource, risk, & quality plans
  • Providing direction & oversight of outsourced studies or insourced to ensure that vendor deliverables are met on time, within budget, & of high quality Identifies and contributes to areas of best practice and process improvements
  • Comfortable working across different cultures & time zones and with internal & CRO / Vendor staff
  • Significant experience leading global clinical trials; awareness of perspectives & regulations for conducting clinical trials outside the U.S.
  • Strong decision-making ability
  • Applies critical thinking and aims to simplify work. Strives for efficiency.
  • Ability to influence, negotiate and manage conflicts

Skills:

  • Clinical trial management experience, including:
    • Leading study team (including Ops and Cross-functional)
    • Vendor management (as appropriate)
    • Management of study timeline & budget Providing study-specific direction to other ClinOps team members
    • Mentoring & coaching of other Ops team members
    • Ensuring adherence to ICH/GCP/local regulations
  • Essential Competencies:
    • Extensive clinical research knowledge (ICH, GCP, FDA guidelines)
    • Leadership skills to ensure timelines, budget, & quality metrics met
    • Excellent written & verbal communication
    • Highly developed interpersonal skills (e.g., team player, collaborative, ability to influence others)
    • Able to effectively organize & prioritize
    • Creative at problem solving, risk mitigation strategies

Education:

  • Life sciences degree or nursing equivalent and relevant
  • Clinical research experience ( 3 yrs)