Director of Clinical Data Oversight
18 hours ago
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 OpportunityYou 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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