Career as Clinical Data Manager at Clinical Development Services Agency

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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
• Essential:
* 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

Job profile
*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
*AE/SAE reconciliation
*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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