Average salary: Rs667,856 /yearly
More statsSearch Results: 41 vacancies
...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...
...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...
...The opportunity is with a Global US based niche provider of Clinical Analytics services.
Skill Set:
• Experience in designing the CRF and input to protocol.
• Experience in writing SAP/RAP, dataset specifications and mock shells.
• Knowledge on CDISC standards
•...
...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...
...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
...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...
...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...
...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...
...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....
...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...
...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...
...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....
...set.
Demonstrates a comprehensive knowledge of database structures and of capturing and storing clinical information as they apply to CRF design, database development, data handling and reporting.
Excellent interpersonal skills and proven ability to operate effectively...
...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...
