Average salary: Rs667,856 /yearly
More statsSearch Results: 35 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...
...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...
...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...
...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...
Rs 6 lakh p.a.
...production of assigned mailing creation that is accurate and efficiently configured for deployment per the client's Campaign Request Form (CRF) instructions including the following:
■ Manages building and testing of campaign builds, including creative rendering, link...
...statistical leadership support for clinical studies including study design, sample size calculations, patient randomization, case report form (CRF) review, statistical analyses, interpretation of data, and reporting of results.
Coordinate the development of analysis plans, table...
...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...
...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...
...staff.
Preferred Skills and Qualifications:
~Certification in clinical data management or related fields.
~Experience with CRF design, MS Project, and analytical tools.
~Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).
~Familiarity...
...product, study supplies, special equipment, safety lab kits, etc.).
In collaboration with the data management group, ensures that the CRF complies with the protocol and Sponsor requirements and ensures queries resolution and data review process follow the study timelines...
...study including assisting in preparing the eCRF, CCGs, DMPs,
DVPs and performing User Acceptance Testing (UAT) if required.
Review CRF / eCRF data for completeness, accuracy, and consistency via computerized edits and
manual data checks.
Generate and close/...
...on edit check specification/integrated data review plan.
• Executes routine data review tasks
• May contribute to the creation of CRF completion guidelines or equivalent data collection documents
• May be responsible for Local lab data entry and local lab data review...
...skills with ability and willingness to work under pressure and manage time and priorities effectively
• Support for MI to prepare CRF (Client Return Forums)
• Tiering & Loan-To-Book data & report management (e.g. keeping a golden source, UCRM update uploads, regular...
...Propose technical solutions adapted to the business and BA needs (Contribute to technical requirements writings)
· Report to CRF central team on a regular basis (KPIs, Roadmap follow-up, incident/bugs tracking, budget consumption)
· Analyze and interpret requirement...
...Responsible for implementation and maintenance of standard template in EDC and DMW. Align with the PDMs to understand the project requirements (CRF and external data) for new programs/projects.
• Responsible for tracking and implementation of the new requests for DMW template...
...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...
...across multiple therapeutic areas, with emphasis on regulatory submissions. An excellent opportunity to work end-to-end programming from CRF collections through Regulatory submission, you will have an exciting opportunity to learn new technologies (like R) and endorse...
...Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure site documents are...
...analyses.
Ensure that documents, specifications, programs/macros are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for Interventional and Non-Interventional Clinical studies.
Maintain efficient...
...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...
