Clinical Data Management Lead
Clinical Data Management Lead
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Salary Not Disclosed
1 Vacancy
Job Description
- We are seeking a skilled Clinical Data Management Lead to oversee the execution of clinical trials.
- This role will be responsible for ensuring highquality data collection review and delivery within scope on time and with precision.
- Lead clinical trial project teams attending internal and external meetings to ensure smooth execution.
- Manage studyspecific data management tasks from protocol review to database lock.
- Develop CRFs and edit specifications per protocol ensuring completeness of user acceptance testing.
- Provide operational support for Medidata RAVE activities including clinical database development and external data transfer documents.
- Maintain ongoing report development and support database lock and archiving activities.
- Review and contribute to CRF development team efforts developing data collection modules outside standard CRF library versions.
- Ensure timely completion of medical coding reviewed and approved by medical monitors.
- Participate in SOP development and mentor junior staff on clinical data management activities.
- Guide clinical data management personnel on assigned projects reviewing study documents as needed.
- Ensure project documentation is archived in a timely manner into the Trial Master File.
- You should have experience working on multiphase multitherapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
- This role requires a postgraduate degree with 6 years of experience or a bachelors degree with 8 years of experience in a relevant field such as Life Sciences Biostatistics Computer Science.
Employment Type
Full Time
