Clinical Data Management Director
21 hours ago
At Miltenyi Biotec, we are a leader in the development of innovative solutions for biomedical research and cellular therapy. We are seeking an experienced Associate Clinical Data Management Director to join our team in Waltham, MA.
About the RoleThis is an exciting opportunity to lead our data management practices and support our hybrid insource-outsource data management approach. As a key member of our team, you will work closely with internal stakeholders to ensure adherence to data management processes, communicate data standards, and establish/oversee Sponsor-CRO data management key performance indicators (KPIs).
Key Responsibilities:- Lead data management activities, timelines, and deliverables from study start to close out.
- Oversee CRO and vendors, participate in study start-up activities, including development, review, and approval of eCRF requirements, EDC database specifications, Data Transfer Specifications, eCRF completion guidelines, Data Management Plans, Data Validation specifications and User Acceptance Testing.
- 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: $120,000 - $150,000 per year.
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