Average salary: Rs667,856 /yearly
More statsSearch Results: 42 vacancies
...within clinical data management systems.
Working knowledge of programming languages: Python, R & R Shiny.
Understanding of protocol, CRF standards, and EDC data structure
Experience in creating reports and visualizations using BI applications such as Tableau and Power...
...Protocol, Statistical Analysis Plan [SAP], Data Management Plan [DMP], Prescription Drug Monitoring Program [PDMP], Case Report Form [CRF], Clinical Study Report [CSR])
Provide high-quality and timely statistical analyses results to support correct and timely decision making...
...follows-up on site invoices throughout the study period.
Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
Verifies document collection status in CRG systems and drives...
...quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as the need arises. Collaborates with the project...
...Senior Statistical Programmer is accountable for:
Provide programming input to the setup of the trial, including but not limited to the CRF, Trial Validation Plan and Data Flow Plan.
Responsible for creating and gathering input to the Specification ADRG for the clinical...
...failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and...
...reconciliation.
Perform under supervision database (EDC) design setup and administration.
Develop database validation specifications CRF Completion Guidelines User Acceptance Testing scripts of data for study databases.
Perform User Acceptance Testing for development...
...an asset.
Experience with cross-over studies is a plus.
Submissions experience utilizing define.xml, creation of annotated CRF, data reviewer’s guides and other submission documents.
Excellent analytical & troubleshooting skills.
Being flexible to...
Remote job
...of study documents to ensure adherence to required SOPs and regulatory requirement
Preparation & review of study documents such as e-CRF, Study plan, Study update, Clinical tables, SDTM, etc.
Responsible for maintenance of ICU and cardiac ambulance including the...
...documentation related to these activities, as needed.
Perform annotation / database update / quality assurance on case report form (CRF) annotations for post-production study changes as applicable.
Participate in UAT when new application release occurs, as applicable....
...development process
Knowledge of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting.
Demonstrated understanding of clinical data system design / development /...
...of the relevant sections of the Trial
~ Master File (local and central). May participate in the design and development of
~ CRFs, CRF guidelines, patient informed consent templates and other protocol
~ specific documents as required. Collaborates with the project manager...
...assist with quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
Assist with the required study...
...pharmaceutical industry
and preferably 2 plus years within clinical data management systems.
~Understanding of protocol, CRF standards, Inform
Terminologies and EDC data structure.
~Knowledge and experience in Programming languages &...
...database.
Contribute to the process of external data integration when necessary (IWRS/Safety DB/ECG/Laboratory/Other).
Develop Non-CRF Data Specifications, RTSM Specification/Guidelines when necessary.
Perform database lock (interim/final) in consultation with PDD...
...external partners
Understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
Knowledge of SQL or SAS software
Experience leading clinical studies as...
...In consultation with concerned stakeholder/vendor/interface, review and approve additional supporting documents/databases including ICF/CRF/SAP, etc
Collaborate with Study Management in providing training to in-house project teams (CRAs, project secretaries/assistants)...
...medium complexity studies
Conduct overall statistical review of TFLs for medium complexity studies prior to client delivery
Review CRF and other study specific specifications and plans
Provide statistical input and review of the CSR for simple studies
The...
...Specifications, datasets, ADRG) and TFLs
2) Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents.
3) Develop SAS programs to produce Analysis datasets, statistical tables,...
...quality to ensure compliance with standard operating procedures.
Required Skills (top 3 nonnegotiables):
1. Develops study specific CRF
2. Programs SAS edit checks and SAS macros
3. Designs and validates clinical databases
Preferred Skills (nice to have)
1....
