Demo

Senior Manager/Associate Director Clinical Operations

The Judge Group
Berkeley Heights, NJ Full Time
POSTED ON 1/25/2025
AVAILABLE BEFORE 4/20/2025

Position Overview :

This role will be responsible to connect science and operations to bring clinical studies to life through the execution of company’s global clinical research programs. She / he serves as a strategic advocate for pipeline assets and provides operational reality to our scientific drugs via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges.

Responsibilities :

  • Develop clinical operational strategy and ensure clinical research programs are executed with quality and efficiency, on-time, within budget, and to meet company objectives.
  • Translate asset strategy into operational execution by developing the clinical operations plan (or strategy) and connecting the science with the business, operations, patients and our customers.
  • Identify and evaluate risks and mitigations at program level to achieving the asset strategy.
  • Interacts with and influences all levels of management and cross-functional team members to achieve program objectives and represents Clinical Operations at senior leader cross functional meetings.
  • Reviews and provides clinical operations content to clinical and regulatory documents.
  • Execute clinical programs in compliance with quality standards (ICH / GCP, Global Regulations, and Company policies and procedures).
  • Strong communication and stakeholder management skills. Is comfortable with not having all the information yet able to drive activities and find solutions to deliver on the program.

Qualifications :

  • Bachelor’s degree or equivalent is required
  • 10 years of Pharma-related / clinical operations related experience (and / or applicable work experience)
  • Must have 8 years (and / or applicable work experience) in clinical research demonstrating a high level of core, technical and leadership competencies through setting and driving strategy.
  • Proven ability in leading a global team in the management and completion of multiple, complex clinical studies.
  • Expertise in Subject Matter and competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)
  • Integral participation in initiatives or advancement strategies for clinical operations
  • Experience in successful study initiation through study completion / primary data analysis and in multiple phases of studies (Phase 1-3)
  • Must possess good communication skills.
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