Senior Clinical Data Manager
New
W
Worldwide Clinical TrialsClinical Research CRO
United StatesFull-TimeSenior
Salary79,000 - 157,000 USD per year
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Job Details
- Experience
- Min of 5 years of experience
- Required Skills
- Project Management
Requirements
- Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related discipline.
- Minimum of 5 years of experience in clinical data management or a related role in the pharmaceutical, biotechnology, or medical device industries.
- Strong knowledge of data management best practices and technologies as applied to clinical trials.
- Strong understanding of clinical trial processes and protocol-related documents.
- Demonstrated independent and autonomous project oversight skills.
- Excellent attention to detail and analytical problem-solving abilities.
- Excellent written and verbal communication skills.
- Strong interpersonal skills to collaborate with cross-functional internal and external teams.
- Proven ability to manage startup, conduct, and close-out phases of clinical studies.
Responsibilities
- Provide fully independent and autonomous leadership of data management services across the full study lifecycle.
- Ensure appropriate resources are allocated to complete all data management activities on time and within budget.
- Prepare essential trial documentation including DMPs, database specifications, edit check specifications, and DTAs.
- Oversee data cleaning activities, UAT performance, and ensure timely database lock.
- Write external vendor reconciliation specifications for programming outputs such as SAEs, IRT, and laboratory data.
- Monitor project scope, budgets, and risks while reporting progress to management.
- Collaborate with internal departments and represent the DM team in internal and external study meetings.
- Provide training, support, and mentorship to other members of the data management department.
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