Global Studies Leader

New York, New York 10016 | Contract

Post Date: 05/01/2018 Job ID: 4190 Industry: Drug Development - Med/Clinical Affairs

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties:
  • 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
  • Distinguishing Requirements of this Role: 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)
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