CLINICAL DATA MANAGEMENT
Full life cycle Data Management Services
Clinical data integrity is chief requirement for successful completion of clinical research at every stage. In addition, data that is clean and reliable can also decide the fate of a clinical trial. As every pharma company aims to market its drug as quickly as possible, it is very important to manage the clinical data as perfectly as possible for a smooth and hassle-free clinical journey.
At Aptitude Solution Inc, we understand that quality data management is the only way to successfully support the vital needs of drug development for quick transit of drug/device into the market. We also believe in providing the highest quality, real time and faster access of clinical data to our clients for faster decisions while keeping the focus on patient safety. Our end to end CDM services uphold a process driven and standardized approach. We offer efficient, reliable and flexible clinical data management services for companies of every size. our goal as Clinical Data Analyst is to discover useful information, form conclusions and support decision makingwe will be accountable for clinical data review and analyzation of real time data for complex, global projects collated from various data sources. We will leverage knowledge of the protocol, key risk indicators, and specialized visualizations to assist with the identification of risk associated trends for their assigned projects. We understand all aspects of the job including data review processes utilized to investigate outliers and trends in the data. we confirm that data quality on initial review meets acceptable standards, and if not acceptable, we escalate appropriately in assigned clinical studies. we track multiple issues/problems, and identifies potential issues before they occur.
We supports implementation of central monitoring activities as requested by 2016 ICH GCP guidelines paragraph 5.04-5.06, specifically by focusing on central monitoring of aggregated data.
We will be doing the following tasks:
- Accurately examine data in a graphical format to obtain insight regarding the information within the data
- Conduct ongoing reviews of clinical trial data using various technologies, analytic and visualization tools to monitor the quality of data, patient safety and relevant risks as per the Risk Log for the study. This may include review via data listings, study specific eCRF and aggregated data through ePremier tools
- Monitor site performance, data trending related to quality and site performance and escalation of those sites not meeting expectations through the regular use of ePremier data visualization tools
- Utilize your central monitoring expertise to provide input to the development and update of the Risk Log for assigned projects
- Represent Data Analytics as the study project team resource to assist in development of the escalation path and action plan when risks are identified in the data for assigned projects
- Maintain effective and timely communication with all team members and documents all communication; attend routine project team calls to discuss findings as appropriate
- Anticipate potential issues and resolve through potential action plans and documents corrective actions
- Review the effectiveness of the recommended actions and escalate for further appropriate actions if no effect is first observed
- Provide direction to site monitors along with the Clinical Lead, for additional remote and on-site monitoring activities for sites at risk, within the scope of the trial monitoring and clinical management plans
- Serve as resource to study sites in resolving queries and/or other identified data collection issues
- Perform remote/phone visits, as required per the CMP and contracted services
- Build efficiencies and the overall value of the Clinical Data Analyst I role and Risk Based Study Execution process at Premier
- Serve as Premier's in-house expert on assigned projects (for example, patient enrollment, data status, and other site metrics)