Career as Clinical Data Manager at Clinical Development Services Agency
Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.
Post : Clinical Data Manager - 2 posts
Emoluments : Up to Rs. 90,000
Duration : The study duration is four years. The initial appointment will be for a period of one year to be continued subject to performance.
Qualifications and Experience
* Educated to Graduation degree level in healthcare field, IT, Computer Applications with 2years in clinical data management (Clinical Data Manager/ Data Validation Associate/ Data Quality Manager).
* Master’s degree in healthcare field, IT, Computer Applications or 4-5 years inclinical data management (Clinical Data Manager/ Data Validation Associate/ Data Quality Manager).
Desirable: Diploma in Clinical research and clinical data management. Familiarity with industry standard CDMS and SAS programming Skills 6-8 yearsof experience in clinical data management
Preparation of Clinical Study Data Management documentss
*Clinical Study Protocol understanding and experience in the preparation of Data Management documents -DMP (Data Management Plan), DVP (Data Validation Plan/ Edit Checks Document), Annotated CRF, Data Entry Guideline etc.
*Quality Check of Database Design, Validation Program, Annotated CRF, Data Extract Views, Laboratory Details,Site and Investigators and Final Data Listings
*Good experience and working knowledge of CRF designing
*Preparation of Data transfer guidelines for external data load and self-evident correction chart.
*Working knowledge of Query management, data cleaning, data freezing and data archival.
*Change Requests and takes approval from sponsor
*Global library review and approval for changes
*Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project
*Sound knowledge of Clinical Database Development tools, logics and techniques and GCDMP
*Working knowledgeof database standards and study development process, CDM SOPs, CDISC & SDTM standards
*Knowledge of medical dictionaries integration and medical coding in the databases.
*Preparing interim reports and review of listings of data for clinical trial status and data extraction in collaboration with the statistician *Maintaining and archiving of clinical study related documents
*Participates in cross functional team meetings & external client meetings as DM representative
*Generate ad-hoc reports as needed
*The data manager will ensure that security of all data is maintained and confidentiality of participants is protected.
*Managing requests for data from external third parties –including liaising with internal staff and external collaborators to provide data in a timely and appropriate manner and maintenance of a database detailing the status of such external data requests.
*Knowledge of Laboratory Information Management Systems (LIMS) to track requisition and specimen status to ensure prompt turnaround time of sample results
*Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and immediately communicating these to the appropriate management representatives to ensure prompt resolution
*Create and/or update laboratory standard operating procedures, as needed
*Verification of information fidelity in the specimen medical record and the electronic database.*Review information relating to the correlation of test results and final reports.
*Releasing test results to physicians in a report format.
*Effective interaction with intra-departments to ensure all required, vital information and documentation is acquired in a timely manner.
*Clinical Lab Support as needed and not limited to: Biorepository functions, Regulatory Audit support, Sample Accessioning and Receiving.
*Lead in preparation of datasets for analysis including data cleaning and ensuring compliance with the data protection.
*Development of Standard Operation Proceduresand training to the study team for the implementation of medical coding in the CDMS.
*Supervise DM activities at the clinical site
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