Global Studies Leader
430 East 29th Street New York, New York 10016 | Contract
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.
- 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
- 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
- Life sciences degree or nursing equivalent and relevant Clinical research experience (3 yrs)