56 Primera Jobs - Page 2

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the informatio...

Hi, We are hiring for the ITES Company for the Clinical SAS + SQL Programmer Profile. Job Description: Minimum 4 years of experience in any CDMS application. To perform a wide range of Clinical Data Management activities resulting in high quality database within stipulated timelines. To provide expertise in programming concepts to the Data Management team Must be able to develop the connection with the stake holders by pro-actively communicating over the calls and handling the queries by resolving them on the spot or later depending on the nature of the problem. Must be able to contribute the solutions to the DMs or Medical scientist for their New requirements either programmatically or conv...

Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. ...

Hi, We are hiring for ITES Company for SAS + CDB Programmer Role. Job description: Programming, specifically J Review, SQL, R and GitHub. Good to have Python. • Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. • Develop library of reusable checks working closely with data engineers and config specialists. • Collaborate with cross functional teams in creating business rules and automated check library across TAU. • Serves as a technical resource for creating data analytics to help with data validation and cleaning. • Provide programming expertise for data cleaning to efficiently ...

Hi We are hiring for the ITES Company for the SAS : J Review Programmer Role Role & responsibilities Programming, specifically Programming, specifically J Review, SQL, R and GitHub. Good to have SAS. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise fo...

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform ...

Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem s...

Hi We are Hiring for the job role of Medical Writer Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinic...

Hi We are Hiring for the job role of Medical Writer Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinic...

Hi We are hiring for Leading ITES Company for SAS+R Programmer Profile. Role & responsibilities: a) Any Graduate b) Minimum of 3 years of experience in SAS + R programming c) Familiarity with data visualization techniques and tools in R d) CDISC knowledge & experience Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualiz...

Hi We are hiring for Leading ITES Company for SAS+R Programmer Profile. Role & responsibilities: a) Any Graduate b) Minimum of 3 years of experience in SAS + R programming c) Familiarity with data visualization techniques and tools in R d) CDISC knowledge & experience Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualiz...

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owne...

Hi , We are hiring for Leading ITES Company for R Biostatistical Programmer Profile. Job Description: Minimum 5 to 8 years experience in Statistical Programming in clinical domain Experience and understanding of ICH GCP principles and clinical drug development process Good knowledge of CDISC SDTM and Adam standards Good knowledge and hands on experience in Base SAS, SAS / STAT, SAS /Graph modules and R Statistical programming Preferred Educational Qualification for the role: Bachelors or Masters degree or equivalent in statistics, mathematics, life science, engineering or computer related subject Essential Experience for the Role : Good knowledge and hands on experience in R Statistical Prog...

Hi , We are hiring for Leading ITES Company for R Biostatistical Programmer Profile. Job Description: Minimum 5 to 8 years experience in Statistical Programming in clinical domain Experience and understanding of ICH GCP principles and clinical drug development process Good knowledge of CDISC SDTM and Adam standards Good knowledge and hands on experience in Base SAS, SAS / STAT, SAS /Graph modules and R Statistical programming Preferred Educational Qualification for the role: Bachelors or Masters degree or equivalent in statistics, mathematics, life science, engineering or computer related subject Essential Experience for the Role : Good knowledge and hands on experience in R Statistical Prog...

Strong exp in understanding Server Architecture, HBA adapters, CNA adapters. Expert knowledge of OS (Linux / Windows / VMware) system level concepts Strong Storage expertise on SAS, SCSI, SATA, ISCSi, DAS, NVMe, SSD & HDD protocols. Required Candidate profile Good knowledge in any of the storage products like 3PAR, Alletra/Primera, Nimble, DELL, Cisco. Good knowledge in Shell & Python. Prepare file defect reports and report test progress Perks and benefits Perks and Benefits

Hi We are hiring for Leading ITES Company for SAS+R Programmer Profile. Role & responsibilities: a) Any Graduate b) Minimum of 3 years of experience in SAS + R programming c) Familiarity with data visualization techniques and tools in R d) CDISC knowledge & experience Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualiz...

Hi We are hiring for Leading ITES Company for SAS+R Programmer Profile. Role & responsibilities: a) Any Graduate b) Minimum of 3 years of experience in SAS + R programming c) Familiarity with data visualization techniques and tools in R d) CDISC knowledge & experience Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualiz...

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owne...

Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem s...

Hi, We are hiring for the ITES Company for the Clinical SAS + SQL Programmer Profile. Job Description: Minimum 4 years of experience in any CDMS application. To perform a wide range of Clinical Data Management activities resulting in high quality database within stipulated timelines. To provide expertise in programming concepts to the Data Management team Must be able to develop the connection with the stake holders by pro-actively communicating over the calls and handling the queries by resolving them on the spot or later depending on the nature of the problem. Must be able to contribute the solutions to the DMs or Medical scientist for their New requirements either programmatically or conv...

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform ...

Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem s...

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owne...

Hi , We are hiring for Leading ITES Company for Data Management Study Point of Contact (DMSPOC) Profile. Job Description: To provide end to end data management services and project management of studies. Ensure compliance with SOPs and training. Primary point of escalation for issue management. Accountable for DM deliverables (including quality and timing) on the project and will be required to provide regular status updates on data completeness, cleanliness to the Data Manager. Point of contact for client POC. Attend meetings with Study Lead Data Manager (SLDM) as and when required, provide inputs to the required documents and activities throughout the course of the trial. Ensure that the t...

Hi We are hiring for Leading ITES Company for SAS+R Programmer Profile. Role & responsibilities: a) Any Graduate b) Minimum of 3 years of experience in SAS + R programming c) Familiarity with data visualization techniques and tools in R d) CDISC knowledge & experience Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualiz...