Director, Data Management Quality & Inspection Readiness

Initial Therapeutics, Inc.; New Jersey; Hybrid; USD 183,100 - 305,200; Full time

Job summary

Initial Therapeutics, Inc. is seeking a Director for Data Management Process, Quality, and Inspection Readiness. This role involves strategic leadership for data management quality and regulatory compliance, ensuring standardized operational excellence while preparing for health authority inspections.

With a focus on developing governance and continuous improvement frameworks, the ideal candidate should possess deep expertise in clinical data management and a proven ability to lead teams towards inspection-ready execution. This hybrid position requires some travel and offers a competitive salary range.

Qualifications

• Minimum of 12 years in Clinical Data Management.
• 5+ years of people management experience.
• Expert knowledge of clinical data management principles.

Responsibilities

• Develop Data Management quality frameworks.
• Lead quality event and CAPA management activities.
• Collaborate with CRO partners on quality events.

Skills

Data Management Quality

Leadership

Regulatory Compliance

Process Improvement

CAPA Management

Education

Bachelor's Degree in Science, Health, Computing or related field

Tools

Data Management Systems

Job description

Initial Therapeutics, Inc. is seeking a Director for Data Management Process, Quality, and Inspection Readiness. This role involves strategic leadership for data management quality and regulatory compliance, ensuring standardized operational excellence while preparing for health authority inspections.

With a focus on developing governance and continuous improvement frameworks, the ideal candidate should possess deep expertise in clinical data management and a proven ability to lead teams towards inspection-ready execution. This hybrid position requires some travel and offers a competitive salary range.