Hello Guys,
Role: Clinical Data Manager Location: Newyork Term: Long term The Clinical Data Manager performs activities pertaining to the conduct of Phase I – III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines. The CDM ensures, from a data management perspective, assigned trials on time, within budget, and with highest achievable quality. Essential Functions Of The Job (Key Responsibilities) · Participate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange. · Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and aging, etc.) and determining appropriate actions in conjunction with study team. · Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines. · Participate in User Acceptance Testing (UAT), as needed. · Participate in Quality Control (QC), as needed. · Responsible for working with the assigned Clinical Database Programmer(s) to ensure the development of the Data Flow Chart(s), Data Transfer Specifications and Import Guidelines. · Assist with site and/or third party vendor training on CDM-related topics. · Responsible for providing data review training and guidance to Sr. Clinical Data Coordinators that are supporting their trial(s). · Perform data review and discrepancy resolution, as needed. · Responsible for archiving trial(s) and associated documentation upon trial(s) completion. · Ensure adherence to Good Clinical Practice and all applicable local and international regulations. Qualifications: · Minimum of 5 years of data management experience is required. · Experience with Electronic Data Capture (EDC) system(s) is required. · Experience with Oracle Inc.’s Inform™ EDC system is preferred. · Oncology and/or inflammatory therapeutic area experience is preferred. · Project management experience (within Data Management) is preferred. · Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred. Thanks, Vidya [email protected] www.aegists.net 732-666-0116 -- You received this message because you are subscribed to the Google Groups "Android Discuss" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To view this discussion on the web visit https://groups.google.com/d/msgid/android-discuss/a4e1ac48-3576-480d-96fc-6e740911453fo%40googlegroups.com.
