Description
Job Responsibilities:- - Provides input to the development of the Study protocol
- - Responsible for keeping the SMT members fully and promptly updated on the status of the data flow and the data quality throughout the life cycle of the clinical trial/Registry
- - Leads the creation of the Clinical Record Form(CRF/e-CRF) and provides oversight for the user testing of the clinical database which is created from the CRF Via key study documents (such as the Data Management Plan, Data Validation Specification and the Data Review Plan
- - Responsible for the completeness, accuracy and the internal consistency of all of the clinical data collected in the clinical trial or disease Registry
- - Collection of any laboratory safety data (including central laboratories) or data from ancillary data sources (such as academic labs, ECGs, pK data etc.)
- - Ensures that the patient data are clean and complete in preparation for any agreed Reporting Event (such as Dry-Run, Interim Analysis, Final Database Lock etc)
- - Ensures all coded items in the study are promptly and consistently coded
- - Routinely attends investigator meetings and may be required to prepare data presentations or PowerPoint presentations for such meetings
- - Works closely with the Medical Director and Drug Safety Review of the clinical data
- - Responsible for the efficient locking of the data in the study/Registry, finalizing the applicable documentation in accordance with relevant SOPs and overseeing the archiving of documentation and clinical data
Job Qualifications:
- - Minimum of four to ten (4-10) years of clinical data management experience in a pharmaceutical or biotechnology company or clinical research organization (CRO) essential, with a BS or higher in a bio-medical discipline (e.g. Biological Sciences, pharmacology etc.)
- - Experience interacting with others for defining and implementing data listings
- - Participation in a regulatory filing, such as in the development of an e-submission or CTD Thorough understanding of regulatory guidelines (such as ICH guidelines E6)
- - Competence in SAS Programming Language will be a positive advantage
- - Proficient in the use of database management systems (such as Oracle Clinical, ClinTrial, Medidata Rave or Oracle INFORM
- - Extensive Previous experience of working in a pharmaceutical marketing environment with data from phase IV clinical trials is an advantage
- - Working knowledge of CDISC SDTM standard is a positive advantage
To find out more about Real please visit www.realstaffing.com