Senior Manager, Data Management
New
R
ReplimuneBiotechnology / Oncology
This position can be based either in our Woburn office or be a remote roleFull-TimeManager
Salary$153,000-$198,000
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Job Details
- Experience
- 10+ years
- Required Skills
- Project Management
Requirements
- Bachelor’s degree in a scientific or technical discipline.
- 10+ years of relevant data management experience.
- Deep knowledge of clinical data management outsourcing with global CROs and niche service providers.
- Expertise in clinical oncology indications, endpoints, data flow, standards, and data quality.
- Strong project management skills with the ability to lead cross-functional teams.
- Experience with eCRF design, database design, and data edit check specifications.
- Experience in UAT and oversight of lab/data reconciliation.
- Proficiency in developing or improving data management SOPs and guidelines.
Responsibilities
- Review and manage DM activities in vendor proposals, budgets, and scopes of work.
- Review and provide input into clinical study documents including protocols, SAP, and CSRs.
- Oversee all data management activities performed by CROs as the internal DM Study lead.
- Review and manage key documents including data management plans, CRF completion guidelines, and SAE reconciliation.
- Oversee eCRF design, database design specifications, and UAT of the clinical database.
- Lead internal study teams in data review and quality issue identification.
- Define and oversee data transfer specifications for external data sources and lab reconciliation.
- Collaborate on implementing electronic systems, data aggregation tools, and emerging EDC technology.
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