Senior Clinical Data Manager
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Job Description
Managing data management operations for clinical projects at Catalyst Clinical Research. Leading technical expertise and ensuring project execution meets sponsor satisfaction.
Responsibilities:
- Oversee, lead, manage and provide technical expertise within the assigned projects.
- Provide fully independent and autonomous leadership of data management services (start up, conduct and close out) across multiple complex global projects/programs.
- Ensure appropriate resources are allocated to complete all DM activities on time and budget.
- Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs).
- Write external vendor reconciliation specifications for programming reconciliation outputs.
- Oversee data cleaning activities.
- Produce metrics to monitor progress of trial activities.
- Ensure all database lock activities are completed on time.
- Represent WorldWide DM at both internal and external study meeting calls.
- Monitor project scope, budgets and risks and alert DM Management of any concerns.
- Liaise with DM Management regularly to discuss progress and issues outstanding.
- Collaborate with internal Worldwide departments working on the same project.
- Provide training, support and mentorship to other members of the DM department.
Requirements:
- Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline — or equivalent relevant experience.
- Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.
- Strong knowledge of data management best practices & technologies as applied to clinical trials.
- Strong understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Independent and autonomous project oversight skills.
- Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.
Benefits:
- Health insurance
- Professional development
- Flexible working arrangements
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