54 Primera Jobs - Page 2

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 visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge 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 ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 375 b) For Position in Hyderabad Search : Job Code # 376

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 Statical Programming in Clinical Domain To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 291 a) For Position in Pune Search : Job Code # 292

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 1 to 2 years of experience in medical writing To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Noida Search : Copy and Paste the link below https://outpace.in/job/narrative-medical-writing-4/

Hi We are looking forward to hire Medical Monitor for our Client. Please go through the JD and Apply Responsibilities: Review protocol and provide suggestions Respond to queries/ clarifications from EC/ IRBs Answer medical questions from sites or project team Respond to queries from sites with regard to protocol Attend drug safety meetings/ external meetings Patient eligibility review Review AE/ SAEs Protocol training to site staff, CRAs etc Attend, participate/ present in investigator meetings Qualification: MBBS/ MD qualification Eligibility: 3 year+ of clinical trial experience Familiar with clinical trials operations Good English communication skills Proficiency in using Microsoft office To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 362 b) For Position in Pune Search : Job Code # 363 c) For Position in Bangalore Search : Job Code # 364

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. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Pune Search : Job Code # 96 b) For Position in Nagpur Search : Job Code # 97

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 for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), EDC build and/or clinical data management experience preferred Experience in AWS preferred Experience setting up automated validation is preferred Knowledge of Data lake and creating interactive Dashboards are preferred Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : J Review Bangalore (Job Code # 87) b) For Position in Nagpur Search : J Review Nagpur (Job Code # 88)

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 convincing them with the technical limitations, if any, along with providing alternative solution. Must have capability to develop new Macros in SAS or modify any SAS Macros that are used globally throughout studies as a part of automation. Preferred Skills: Excellent interpersonal and communication skills Capability to lead by motivation and exle. Strong knowledge in SAS macros is required. General knowledge of Clinical Trials and Pharmaceutical Industry Oracle/PL SQL, CDMS like SAS, Inform etc Key Skills: a) Minimum 4 years of experience in any Clinical Data Management application. b) Should have Oracle/PL SQL, CDMS like SAS, Inform etc c) Any Medical Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Pune Search: Job Code # 483 b) For Position in Bangalore Search: Job Code # 484 c) For Position in Hyderabad Search: Job Code # 485

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 visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge 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 ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 375 b) For Position in Hyderabad Search : Job Code # 376

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 compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55

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 visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge 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 ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 373 b) For Position in Pune Search : Job Code # 374

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 such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : EDC Veeva Mumbai (Job Code # 181) b) For Position in Pune Search : EDC Veeva Pune (Job Code # 182) C) For Position in Bangalore Search : EDC Veeva Bangalore (Job Code # 183)

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 timelines & quality are met as per study requirement. Resource estimation for the study and ensuring right resources are available for the study based on requirement. To oversight the end-to-end data management activities for assigned studies. Risk identification, mitigation and issue escalation to the appropriate stakeholders. Skillsets required: Ability to represent Data Management at all levels and is capable of targeting information to the respective audience. Ability to influence key project roles or Study Team members to meet the overall goal of the study. Ability to build influential networks with client and stakeholder management. Ability to develop solutions for cross functional challenges. Develops recommendations beyond own area of expertise. Knowledge of ICH GCP & CDISC requirements. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 297 b) For Position in Pune Search : Job Code # 298 c) For Position in Bangalore Search : Job Code # 299

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 clinical document for regulatory submission, if required. * To work in coordination with all the members in the study team- internal and external for the development of clinical documents. * Share project timelines amongst the study team for the development of document. * Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. * Review statistical analysis plans and table/figure/listing, when required. * Ensure uniformity and consistency in the scientific content of the regulatory documents * Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. * Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. * Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. * Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. * Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. * Plan and organize project and non-project meetings, as and when required To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writer Mumbai ( Job Code # 56) b) For Position in Pune Search : Medical Writer Pune ( Job Code # 57)

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 clinical document for regulatory submission, if required. * To work in coordination with all the members in the study team- internal and external for the development of clinical documents. * Share project timelines amongst the study team for the development of document. * Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. * Review statistical analysis plans and table/figure/listing, when required. * Ensure uniformity and consistency in the scientific content of the regulatory documents * Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. * Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. * Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. * Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. * Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. * Plan and organize project and non-project meetings, as and when required To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writer Mumbai ( Job Code # 56) b) For Position in Pune Search : Medical Writer Pune ( Job Code # 57)

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 ensure high quality data. • Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. • Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. • Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. • Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) • Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable • Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), • EDC build and/or clinical data management experience preferred • Experience in AWS preferred • Experience setting up automated validation is preferred • Knowledge of Data base and creating interactive Dashboards are preferred • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) Key Skills: a) Minimum 3 years of Experience in SAS CDB Programmers with R programming. b) Good to have Python knowledge c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Pune Search : Job Code # 84 b) For Position in Nagpur Search : Job Code # 85 c) For Position in Bangalore Search : Job Code # 86

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. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Pune Search : Job Code # 96 b) For Position in Nagpur Search : Job Code # 97

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Roles and Responsibilities: 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 clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writing Mumbai (Job Code # 56) b) For Position in Pune Search : Medical Writing Pune (Job Code # 57)

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 1 to 2 years of experience in medical writing To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Noida Search : Copy and Paste the link below https://outpace.in/job/narrative-medical-writing-4/

Proficient in working with HPE storage arrays such as 3PAR, Primera, Alletra, and Nimble. Skilled in the installation and configuration of HPE storage arrays (3PAR/Primera/Alletra/Nimble). Ability to troubleshoot SAN fabric connectivity issues. Expertise in switch configuration, updates, and executing fabric designs, including tasks like structured cabling in data centers. Experience in troubleshooting host and storage issues. Knowledge of firmware updates for 3PAR/Primera/Alletra/Nimble arrays. Proficient in setting up local and remote replication. Hands-on experience with Brocade and Cisco fabric switches. Working knowledge with operating systems: Basic networking and OS knowledge on Windows, Linux and ESXi Managing VMware infrastructure (create, migrate and deletion.) VM Hardware Consolidation/ Support Assist Lab Support team to perform Hardware movement & Hardware Optimization. Update and track changes PAC/ Asset audit sheet. Preferred: Experience in infrastructure automation using Python Role & responsibilities Mail id share cv s tammali.nagarjuna@mphasis.con Perks and benefits

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Indore Search : Job Code # 228 b) For Position in Ahmedabad Search : Job Code # 229

Hi, We are hiring for Leading ITES Company for Validation Associate Profile. Job Description Minimum 3 years as a Validation Associate is required. 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification (DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through the entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failures. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenarios. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare the InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slice variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets Document inconsistencies Key Skills: a) Min 2 years of experience in eDC or non eDC b) Edit checks validation & script creation in any eDC systems like InForm, Veeva, Rave is required c) Any Graduate WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 173 b) For Position in Ahmedabad Search : Job Code # 175

Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people live and work. We help companies connect, protect, analyze, and act on their data and applications wherever they live, from edge to cloud, so they can turn insights into outcomes at the speed required to thrive in todays complex world. Our culture thrives on finding new and better ways to accelerate what’s next. We know diverse backgrounds are valued and succeed here. We have the flexibility to manage our work and personal needs. We make bold moves, together, and are a force for good. If you are looking to stretch and grow your career our culture will embrace you. Open up opportunities with HPE. Job Description: HPE Operations is our innovative IT services organization. It provides the expertise to advise, integrate, and accelerate our customers’ outcomes from their digital transformation. Our teams collaborate to transform insight into innovation. In today’s fast paced, hybrid IT world, being at business speed means overcoming IT complexity to match the speed of actions to the speed of opportunities. Deploy the right technology to respond quickly to market possibilities. Join us and redefine what’s next for you. What you’ll do: The candidate provides Operate, Admin and Consulting support on Storage infrastructure and the Operating system in accordance with contractually established terms and conditions and established technical standards. Provides technical input, solutions, and recommendations to deal pursuit. Engaged in and provides support for transition/ transformation efforts. Provides IT infrastructure and/ or application infrastructure lifecycle technical support, including planning, project management, installation, on- going management/ monitoring/ troubleshooting, and de- installation, following operational policies and processes that are compliant with industry standards (e.g. Information Technology Infrastructure Library (ITIL)). Manages the technical/ service relationship between the company and the customer, and between the company and subcontractors/ vendors. Works with the key customers and/ or internal businesses/ end user representatives (Infrastructure Support Managers, Client Manager and the Account Delivery Manager) to retain customers and build the business. Key Responsibilities: Resolve customer’s issues via the telephone, email or remote sessions. Reproduce issues in-house and responding back in a timely manner. Regular follow ups with customers with recommendations, updates and action plans. Identify and escalate issues in a timely manner to vendor according to Standard Operating Procedures. Leverage internal technical expertise, including peers, mentors, knowledge base, community forums and other internal tools, to provide the most effective solutions to customer issues. Collaborate with other CoE/HW teams in diagnosing and isolating the cause of complex issues. Provide consulting support in his/her area of expertise Maintain quality on case documentation, SLA timeframes and operational metrics. Performs within the Productivity Measure of the team (scorecard) Incident Management: Resolve single and cross technology incidents independently. Lead the team members to resolve complex or cross technology incidents. Escalation Management: Identify, manage, and lead technical escalations. Participate in formal Escalation when required to support escalation especially during crisis. Problem Management: Proactively and reactively look for solutions to prevent problems from occurring in team/technology area. Perform Trend and Root cause analysis. Change Management/Implementation: Independently prepare, review, implement, rollback and test plan for change records. Perform risk and impact analysis for changes, May lead or participate in a Change Advisory Board. Patch and Security Management: Apply patch and security changes per policy. Proactively monitor the environment for patch compliance. Analyze patches for compatibility with each customer or internal infrastructure environment. Configuration Management: Ensure Configuration Management Database (CMDB) entries are complete and accurate. Must Have: Technical knowledge on Object, File & Block storage with cloud data management solutions – Installing, Configuring & Troubleshooting of at least 2 of the storage skills Storage, SAN, Compute, Java. Adequate knowledge on HPE storage (Nimble, 3PAR, Primera, MSA) Firmware and management experience on above Storage & Servers Basic Operating Systems Knowledge – Install, configure, administration and troubleshoot RHEL/SUSE ] Knowledge on SAN, NAS technologies (Ethernet / iSCSI, FC, FCOE) Performed routine Performance Analysis, Capacity analysis, security audit analysis reports to customer for necessary planned changes Troubleshooting performance related issues on HW and Operating system Should be ready to work in 24x7 rotational shifts and on weekends. Good written and verbal communication skills (Mandatory). Zeal for going the extra mile to solve customer issues. Complex troubleshooting experience and Logical Problem-solving approach Ability to work in a Solution environment, collaborating across Technology Teams. Good to have: Certification on SAN, Storage Operating Systems Knowledge – administration and support on Linux, VMware, Windows HyperV, Linux/Microsoft/VMware VCP or equivalent experience/certification will be an added advantage Tools Knowledge on ServiceNow Must achieve excellent customer satisfaction. Take ownership and work with high productivity and efficiency. Support other team members and seek their advice to make decisions on complex issues. Deliver trainings when required. Technical Skills: S/he will demonstrate an in depth understanding of several products in more than one functional area involving usage, configuration, and interaction with other products. S/he must possess a balance of very well-developed troubleshooting, technical communication, and written skills along with extensive product knowledge and skills. Candidate should have excellent technical communication skills both verbal and written. Interpersonal Skills: Self-Starter - Takes independent action to identify and solve problems. Seeks out relevant information needed to make decisions. Gets involved with new initiatives. What you need to bring: Bachelor’s degree in Engineering (or Equivalent). Experience: Minimum 6-7 years of experience in Storage administration support Should possess strong knowledge of Storage, SAN, Compute, Object/Block/File Storage technology and good understanding of Parallel & distributed file system. Additionally other domains such as networking/database Flexible to work in 24X7 support environment ITIL certification is an added advantage Additional Skills: Accountability, Accountability, Action Planning, Active Learning (Inactive), Active Listening, Bias, Business Growth, Business Planning, Coaching, Commercial Acumen, Creativity, Critical Thinking, Cross-Functional Teamwork, Customer Experience Strategy, Customer Solutions, Data Analysis Management, Data Collection Management (Inactive), Data Controls, Design Thinking, Empathy, Follow-Through, Growth Mindset, Intellectual Curiosity (Inactive), Long Term Planning, Managing Ambiguity {+ 5 more} What We Can Offer You: Health & Wellbeing We strive to provide our team members and their loved ones with a comprehensive suite of benefits that supports their physical, financial and emotional wellbeing. Personal & Professional Development We also invest in your career because the better you are, the better we all are. We have specific programs catered to helping you reach any career goals you have — whether you want to become a knowledge expert in your field or apply your skills to another division. Diversity, Inclusion & Belonging We are unconditionally inclusive in the way we work and celebrate individual uniqueness. We know diverse backgrounds are valued and succeed here. We have the flexibility to manage our work and personal needs. We make bold moves, together, and are a force for good. Let's Stay Connected: Follow @HPECareers on Instagram to see the latest on people, culture and tech at HPE. #india #operations Job: Services Job Level: Specialist HPE is an Equal Employment Opportunity/ Veterans/Disabled/LGBT and Affirmative Action employer. We are committed to diversity and building a team that represents a variety of backgrounds, perspectives, and skills. We do not discriminate and all decisions we make are made on the basis of qualifications, merit, and business need. Our goal is to be one global diverse team that is representative of our customers, in an inclusive environment where we can continue to innovate and grow together. Please click here: Equal Employment Opportunity. Hewlett Packard Enterprise is EEO F/M/Protected Veteran/ Individual with Disabilities. HPE will comply with all applicable laws related to employer use of arrest and conviction records, including laws requiring employers to consider for employment qualified applicants with criminal histories.

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Indore Search : Job Code # 228 b) For Position in Ahmedabad Search : Job Code # 229

Hi, We are hiring for Leading ITES Company for Validation Associate Profile. Job Description Minimum 3 years as a Validation Associate is required. 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification (DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through the entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failures. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenarios. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare the InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slice variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets Document inconsistencies Key Skills: a) Min 2 years of experience in eDC or non eDC b) Edit checks validation & script creation in any eDC systems like InForm, Veeva, Rave is required c) Any Graduate WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 173 b) For Position in Ahmedabad Search : Job Code # 175

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Job Description: Experience : 4 - 11 years of experience in Medical Writing domain. Location: Mumbai, Pune, Bangalore Salary: 8 LPA to 12 LPA To Connect WhatsApp 'Hi' @9151555419 and search for Job in Mumbai / Pune / Bangalore Roles and Responsibilities: 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 clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writing Mumbai (Job Code # 56) b) For Position in Pune Search : Medical Writing Pune (Job Code # 57)