Opening for Asst. Clinical Data Manager @ PharmaNet/i3
PharmaNet/i3 is one of the world’s leading providers of contract drug development services, we recognize you have a choice of where you seek employment. Here’s why PharmaNet/i3 should be at the top of your list.
We seek individuals with a desire to excel in their fields, pursue excellence, and develop intelligent solutions by applying their knowledge and experience. We encourage continuing professional development and offer incentives and awards, competitive benefits, and opportunities for career growth. We have a culture of mutual respect for each other and our clients, and an absolute commitment to quality in everything we do.
This position assists the Clinical Data Manager with the process of cleaning & validating data in clinical trials.
This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in the consultation with the Director, Data
- Assists the Clinical Data Manager in creating, reviewing and processing Data ClarificationForms and updating clinical databases. Utilizes simple reporting tools to assess outlier values and summarize results
- Assists in the set up of patient and investigator information within the Oracle Clinical and Integic systems. Routinely maintains tracking/inventory and identifies missing CRFs
- Assists in troubleshooting CRF receipt and page numbering issues within Integic.
- Assists the Clinical Data Manager in preparation and performance of QC reviews.
- Assists with maintaining and updating Data Management Plans and any other relevant Data Management documentation as assigned by Clinical Data Manager
- Assists with Data Entry and Reconciliation, as needed or assigned.
- Assists in review of manual data listings as needed.
- Assists with start-up activities like database testing, validation procedure testing as and when required.
- Assists with SAE reconciliation. Understands the data that SAEs are reconciled against and make decisions on what to query
- Assist with laboratory or any external (third party) data reconciliation activities
- Assists the Clinical Data Manager in preparation and distribution of study status reports.
- Assists the Clinical Data Management team in other miscellaneous activities as required.
- Stay abreast of information relevant to data management processes through literature reviews, attendance at meetings and conferences
- Knowledge of applicable regulatory rules/guidelines
- Work effectively with peers and sponsors, as needed.