Description
Core Duties-Assisting with the development of clinical data management study documentation, and supporting the review in accordance with existing standards.
-Responsible for the execution of the data review strategy for studies
-Initiation and management of the data clarification process by coordinating with other stakeholders to ensure appropriate resolution to all data clarifications prior to database lock
-Conducting activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines, as well as company policy and procedures
-Using defined department metrics as a framework for timely and quality clinical data management deliverables
-Executing the clinical data management operations against project timelines, and any other priorities
Necessary Experience
-Degree or equivalent in Clinical Research, Computer Science, Project Management or related field: 4 years experience, or BS/BA/MS degree with 2 years experience
-Minimum 2 years experience within clinical data management organization, medium-large Pharma or CRO is preferred
-Intermediate knowledge of Research and Development and an understanding of regulatory guidelines/ requirements related to R & D (e.g. ICH, GCP, safety reporting)
-Intermediate knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.)
-Analytical and problem solving skills
This is an invigorating opportunity to effectively interact with and influence others without direct reporting relationships while carrying out the execution and development of clinical data to ensure accurate and timely completion for a highly established pharmaceutical company. Please send over your latest CV and contact me immediately to be considered for an interview.
Regards,
Joyce
Keywords:
Irvine, California, Pharmaceutical, Clinical Data Analyst, Clinical Data Manager, Clinical Data Management, Global, ICH, CRF, Data Management Plan, Study Data Manager, Study Data Associate, USA, Contract, InForm, Oracle Clinical, Powerpoint
To find out more about Real please visit www.realstaffing.com