Clinical Process Management Director

4 days ago


Indianapolis, Indiana, United States BioSpace, Inc. Full time
Job Title: Associate Director, Clinical Process Management

At BioSpace, Inc., we are dedicated to delivering innovative solutions that transform the way we work. We are seeking an experienced Associate Director, Clinical Process Management to join our team.

About the Role:

The Associate Director, Clinical Process Management will be responsible for designing, sustaining, and improving the efficiency and effectiveness of global processes within our Clinical Trial Foundations (CTF) department. This role will apply technical and process management expertise to effectively manage assigned processes, ensuring they are compliant, fit-for-purpose, and efficient.

Key Responsibilities:
  • Establish clear understanding of assigned processes, including clarity of process inputs, outputs, and dependencies.
  • Lead project teams through development of process maps, process documentation, and personnel qualification strategies.
  • Partner with Process Owners to ensure processes integrate with the end-to-end clinical development process.
  • Propose qualification requirements for individuals executing processes.
  • Define and evaluate metrics to monitor process performance and make recommendations for improvement.
  • Understand external environment changes and lead development of action plans as needed.
  • Influence key stakeholders on process design, timing, and implementation.
  • Collaborate with Process Owners, functional leaders, and subject matter experts to ensure process execution expectations are clear.
Requirements:
  • Bachelor's Degree in a science- or health-related field.
  • Minimum of five years experience in drug development.
  • Demonstrated influence with peers and management.
  • Proven ability to lead change and synthesize information from multiple sources.
  • Experienced in drug development and/or pharma project management.
  • Understands quality systems and process management.
  • Six Sigma Black Belt or Green Belt experience.
About Us:

BioSpace, Inc. is a global healthcare leader dedicated to helping individuals with disabilities engage in the workforce. We are an EEO/Affirmative Action Employer and do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

We offer a dynamic work environment and opportunities for professional growth and development. If you are a motivated and experienced professional looking to make a difference, we encourage you to apply for this exciting opportunity.



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