54 Primera Jobs - Page 3

Hi, We are hiring for the ITES Company for the Trial Statistician Role. Job Description Develop documents e.g. - Clinical Trial Protocol (CTP) - Trial Statistical Analysis Plan (TSAP) - Randomization specifications & initiate randomization scheme creation Participate in the development of Integrated Quality and Risk Management (IQRM) plan and MQRP Support Trial Data Manager (TDM) - Review the data management plan (DMP) and data collection specifications distributed by TDM - Support treatment assignment in SDTM - Provide input to and review Data Review Plan (DRP) prepared by TDM Participate and provide input in meetings (e.g., Trial Oversight Meeting (TOM), organized by CTL; investigators meeting Create and maintain documents in BDS TMF Plan, handle and communicate about trial-specific statistical topics and issues e.g., Sample Size Calculation, Statistical Analysis Strategy Organize and chair Result Planning Meeting (RPM), prepare and participate in the Result Alignment Meeting (RAM) Support TPROG for TSAP implementation and statistical QC of programs, Finalization of QC/Validation. Participate in preparation of Clinical Trial Report (CTR) Handle unexpected data after final data delivery Wrap-up TOM Specify non-CTR specific analyses, Planned/Ad hoc data delivery during trial conduct, e.g. interim analysis Support electronic submission Data delivery at final trial closure, Give input to public disclosure of clinical trial results (CT.gov, EudraCT, etc.) Key Skills: a) Qualification: statistical background (B.Sc. & M.Sc. Statistics) b) Should have experience in Sample size, Biostatistician, Mock shell, Sample sizing calculation, Statistical Analysis Plan(SAP), Statistics c) Knowledge of Clinical Trial Protocol, Clinical Trial Report To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) Search : Job Code # 77

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 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