Clinical Data Management Manager @ Amgen
- Project level coordination of and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines, and approve database locks and unlocks.
- Ensure that quality control checks are occurring such that quality databases are delivered.
- Develop and co-ordinate project level training for data management staff.
- Review and approve study specific training and lead vendor results and relationship at the project level.
- Communication of project level issues including processes, timelines, resourcing, performance, etc.
- Review of all study level non-DM documents for awareness and project level consistency.
- Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level.
- Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
- Bachelors degree or equivalent in life science, computer science, business administration or related discipline
- Broad and proven experience in life sciences or a medically related field including experience in biopharmaceutical clinical research experience
- Extensive Data Management experience in a global organization
- Previous experience at or oversight of outside clinical research vendors (CRO’s, central Labs, vendors, etc..)
- Knowledge of Good Clinical Practice, Drug development and clinical trials processes, clinical trial databases and applications, Quality Management, Regulatory filings and inspections, Risks analysis, Process improvement methodologies is essential
Experience Level: Junior/Associate
Work From: Onsite United States of America
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