We Are A Talent Community Of Experts United In Our Pursuit To Make An Impact.
We serve life sciences and consumer based companies of all sizes by applying deep industry experience to solve complex problems, consult, innovate and collaborate.
We are actively recruiting for the following skillsets:
- Experience creating, reviewing and writing patient profiles and narratives; utilizing that experience, clinical reviewers review patient profiles to determine if the data can be accurate from a clinical standpoint and are consistent within a patient.
- Review clinical trial data as outlined in the study’s data review plan (DRP). Review the protocol and associated guidelines/documents to understand how data should be collected and then review key data points to determine whether there are potential quality issues.
- Perform checks within a case report form (CRF) and cross-checks (across CRF’s) to ensure that data are robust and reasonable.
- Perform check and, if warranted, reconciliation of clinical database and safety database in relation to serious adverse event (SAE) reporting.
- Perform statistical programming of datasets and tables, listing and figures (TLF’s), to ensure items such as:
- Correct and thorough implementation of algorithms (specified in the SAP and or SDTM specs and/or ADAM specs)
- Correct titles and footnotes (match the TLF specs
- Correct representation of all treatment arms
- Perform programmatic checks of the data for correctness and consistency (within a CRF and across CRF’s)
- Work with clinical reviewers to further investigate data-related items found during clinical review.
Data Management Reviewer
- Review data management (DM) aspects of studies, including proper DM plans (e.g. DMP; Data transfer agreement; edit specifications) are in place, proper oversight provided, data adequately controlled over the life of the study. Identify potential DM documentation issues.
- Ensure that the data in the database and in the data sets are of good quality and are traceable. Identify discrepant data and potential data issues, via data checks (within a CRF) and cross-checks (across CRF’s).
- Work with clinical reviewers on further exploration of the database to resolve questions/issues from the clinical reviewers.
- Raise queries and unsure the resolution of the queries is adequate and appropriate.