Lead Clinical Data Manager Job at Cmed
Cmed is seeking an east coast based Lead Clinical Data Manager with a minimum of 5 years of data management experience for this client dedicated opportunity. This position is fully remote.
General:
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Cmed HR or Recruitment Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Cmed may directly contact for employment application.
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General:
- Follow-up of Service Provider (SP) deliverables execution as per plan/contracts (scope of work)/timelines
- Follow-up of Service Providers activities with stakeholders (meeting, action/CAPA log)
- SP risk assessment/mitigation review
- SP oversight guidance implementation and compliance follow-up
- Review of retro planning for key milestones
- Reporting/alerting as per communication plan
- Budget tracker development and maintenance (invoice amount validated & forecast)
- (e) TMF maintenance, including QC
- Scope of work/RFP validation
- Mock CRF development, eCRF
- Validation/review of DM document/plans from SP: Data Management Plan, Validation Plan, eCRF completion guidelines, validation listing, annotated CRF, data transfer agreement, communication plan, training slides kit
- Specifications for (S)AE notification tool and tests performed (SAGA),
- Safety reconciliation plan development
- User Acceptance Test, test transfer QC plan
- DM section of study documents review (e.g., Centralized Monitoring Plan, Monitoring Plan)
- QC (QC plan and tracker)
- Centralized monitoring activities as per plan verified (Patient Data Validation, AE Dedicated Review, Medical Review, Data review and reconciliations) and updated plans as needed
- Study reports review (SDTM issue report, data review and surveillance report, deviations)
- Final database/website closure by Service providers, budget reconciliation, material/access retrieval, archiving.
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Cmed HR or Recruitment Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Cmed may directly contact for employment application.
Please Note :
bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.