Director of Clinical Data Oversight

18 hours ago


Waltham, Massachusetts, United States Miltenyi Biotec Full time

We are a dynamic company that empowers innovation and growth. As a seasoned Associate Clinical Data Management Director, you will have the opportunity to drive our data management practices forward and support our hybrid insource-outsource data management approach. This is an exceptional chance to join our team in Waltham, MA and make a lasting impact on our organization.

About the Opportunity

You will be responsible for overseeing CRO and vendors, participating in study start-up activities, developing, reviewing, and approving eCRF requirements, EDC database specifications, Data Transfer Specifications, eCRF completion guidelines, Data Management Plans, Data Validation specifications, and User Acceptance Testing.

Key Responsibilities:
  • Remain flexible to organizational needs, explaining risks and benefits associated with possible solutions to data management challenges as they arise.
  • Provide accurate study status updates, timelines, and proactive communication of Data Management risks and mitigations.
  • Ensure that data quality and timelines for Data Management support organizational needs and business goals.

What You'll Need:

  • A minimum of 5 years' experience in data management within a sponsor organization with lead experience; or equivalent combination of education and experience.
  • Oncology and cell therapy experience highly desirable.
  • Prior GCP training and understanding of industry best practices to support drug development programs and submissions through BLA/ MAA are required.

Earnings Potential: $130,000 - $160,000 per year.



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