Clinical Data Management Lead
2 days ago
We are seeking a highly skilled Clinical Data Management Lead to join our team at Daiichi Sankyo. The successful candidate will be responsible for managing end-to-end delivery of data management services for assigned projects/studies, collaborating with Contract Research Organizations (CROs) and other vendors to ensure high-quality deliverables are on time and within budget to support drug development processes and global submissions.
Key Responsibilities- Leadership, Direction, and Strategy: Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies, proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies.
- Project Management: Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting), provides oversight for Data Management CRO and other third-party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
- Functional Expertise: Reviews/approves clinical study-related documents (e.g., Protocols, Data Management Plan, Clinical Study Reports), leads and drives the data review process in collaboration with the study team to ensure data quality, participates in audits and inspections.
- Operational Efficiency / Continuous Improvement: Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes, may participate in process improvement initiatives.
- Education: Bachelor's Degree in life sciences or related field (or equivalent experience) required, Master's Degree in life sciences or related field (or equivalent experience) preferred.
- Experience: 4 or more years data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO) required.
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Clinical Data Management Lead
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeAbout the RoleWe are seeking a highly skilled Clinical Data Management Lead to join our team at Daiichi Sankyo. As a key member of our data management team, you will be responsible for ensuring the high-quality delivery of data management services for assigned projects/studies.Key ResponsibilitiesLeadership and Direction:Develop and implement data management...
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Clinical Data Management Lead
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeAbout the RoleWe are seeking a highly skilled Clinical Data Management Lead to join our team at Daiichi Sankyo. As a key member of our data management team, you will be responsible for ensuring the high-quality delivery of data management services for assigned projects/studies.Key ResponsibilitiesLeadership and Direction: Establish data management strategies...
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