Career for Clinical Data Manager at Clinical Development Services Agency | Salary up to 90000 per month
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
Projects : “Translation Research Consortium for Establishing Platform Technologies to Support Prophylactic and Therapeutic Strategies for Dengue Discovery to Proof-of-Concept”
Consolidated salary per month : 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.
Age : Up to 45 years
• 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 knowledge of 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 Procedures and training to the study team for the implementation of medical coding in the CDMS.
• Supervise DM activities at the clinical site.
Qualifications and Experience & Desirable
• Educated to Graduation degree level in healthcare field, IT, Computer Applications with 6-8 years in clinical data management (Clinical Data Manager/ Data Validation Associate/ Data Quality Manager). OR
• Master’s degree in healthcare field, IT, Computer Applications or 5 years in clinical 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 some programming skills
• Preparation of Clinical Study Data Management documents
• Good management & leadership skills
• Familiarity with GCP, US-FDA 21 CFR 11, regulatory requirements and data standardization guidelines.
• IT literate (experience with Microsoft based applications and other CDMS applications)
• Must have experience in handling EDC tools
• Validation programming
• Must have understanding of clinical trials and familiarity with clinical data management functions.
• Good interpersonal, verbal and written communication skills.
• Client focused approach to work.
• A flexible attitude with respect to work assignments and new learning.
• Meticulous attention to detail.
• Effective time management in order to meet metrics or team objectives.
• Commitment to project and team goals.
• Must be able to work independently but seek guidance when necessary.
• Team player with outstanding inter-personal, negotiation skills and organizational skills.
• Sense of urgency in completing assigned tasks
• Exhibits a sense of urgency about solving problems and completing work.
• Shows commitment to and performs consistently high quality work.
• Ability to model behaviors and ethics in line with CDSA Mission and Vision.
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