Average salary: Rs1,075,000 /yearly
More statsSearch Results: 13 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...
...experience in 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 & experience in python or...
...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...
...Implementation and adherence to Project standards template in EDC and DMW.
Align with the PDMs to understand the project requirements (CRF and external data) for new programs/projects.
Ensure the design and set-up of study databases for clinical trials are aligned across...
...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 May perform sample size calculation for Clinical Pharmacology studies under the...
...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 trial...
...you to join us on our mission to shape the future of clinical development.
Responsibilities:
What you will be doing:
Review CRF/eCRF data for completeness, accuracy and consistency via computerized edits and manual data checks.
Generate and close/resolve data...
...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 and...
...with Machine learning techniques like K-Means Clustering, EM Algorithm, Bayesian Classifier, Multinomial Logistic Regression, SVM and CRF along with Ensembling methods.- 2+ years of experience in building forecasting models using time-series techniques like smoothing techniques...
...chart, electronic CRFs (eCRF), External Specifications, and SDTM Domains.
Prepare & review metadata specification (as relevant) and CRF. Submit requests to Standards Teams to either deviate from an existing standard or use a trial-specific element in alignment with the Lead...
...~ Strong CATIA , DMA ENOVIA skill to perform design activity.
~ Desirable:
~ Rolling stock structure design
~ Knowledgeable of CRF manufacturing
~ Meshing tool & basic hand calculation
Competencies & Skills
Structural Design
Sheet Metal Design
CATIA...
...including eDiary, DCFs, NTFs, etc.), Regulatory Documents, Drug Release/Accountability paperwork, Source Document templates, Case Report Form (CRF) templates, Informed Consent Forms, Adverse Events, Dosing Logs, Protocol Deviations, completed CRFs and Clinical Reports.
Conduct...
...activities. Handle queries from CRO / site / Ethics committees
4) Protocol Development and Review of study documents (protocol, ICF, CRF, IB, SAP and CSR) to ensure safety, regulatory and ethical compliance as per existing guidelines
5) Provide medical training to...
