Senior Manager

6 days ago


Boston, Massachusetts, United States Noema Pharma Full time
About the Role

Noema Pharma is a clinical-stage biotechnology company focused on developing novel therapies for debilitating central nervous system (CNS) disorders.

We are seeking a highly experienced Senior Manager to lead our Clinical Trials Team in the execution of global clinical trials in neuroscience.

Key Responsibilities
  • Lead Clinical Trials Planning and Execution: Develop and oversee clinical trial budgets, timelines, and resource allocations to ensure successful trial execution.
  • Collaborate with Cross-Functional Teams: Work closely with clinical operations, clinical development, regulatory affairs, and data management teams to ensure seamless trial implementation.
  • Interface with Key Stakeholders: Foster strong relationships with CROs, investigators, key opinion leaders, and study sites to ensure effective communication and trial progress.
  • Monitor Trial Progress and Quality: Review data quality, identify potential issues, and implement corrective actions to ensure trial integrity.
  • Stay Current with Industry Trends: Stay up-to-date with industry trends, regulatory guidelines, and scientific advancements in neuroscience to inform trial strategies.
  • Contribute to Clinical Development Plans: Develop and contribute to clinical development plans and study protocols to ensure trial readiness.
Requirements
  • Advanced Degree in a Relevant Scientific Discipline: PhD, MS, MPH, or equivalent in a relevant scientific field.
  • At Least 7 Years of Experience in Clinical Trial Management: Proven track record of successfully leading global clinical trials in neuroscience, including project management.
  • Regulatory Knowledge and Experience: In-depth knowledge of GCP, ICH guidelines, EU CTR, US FDA CFR, and other relevant regulatory requirements.
  • Leadership and Communication Skills: Strong leadership and communication skills, with the ability to collaborate effectively across diverse teams and cultures.
  • Organizational and Problem-Solving Abilities: Exceptional organizational and problem-solving abilities, with proficiency in project management tools and systems.


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