9 Edit Checks Jobs

About ProcDNA: ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 300+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey We are currently seeking a Programmer Analyst with a strong hands-on experience in EDC platforms such as Medidata RAVE, InForm, Central Designer, or Veeva Studio. The ideal candidate will possess a solid understanding of clinical data standards, protocol interpretation, and the ability to build high-quality, compliant EDC databases. As a Programmer Analyst, you will play a crucial role in supporting the end-to-end development of clinical databases and ensuring data integrity throughout the trial lifecycle. Your responsibilities will include interpreting clinical trial protocols to design eCRFs and build databases using Medidata RAVE, InForm, Central Designer, or Veeva Studio. You will be responsible for configuring systems, implementing edit checks, dynamic rules, and custom functions (C# for RAVE) based on DVS. Additionally, you will conduct technical and functional reviews, support Sponsor Acceptance Testing (SAT), and ensure accuracy across all database components. You will also manage protocol amendments, metadata updates, lead ICRM/SAM meetings, and resolve issues in QC, UAT, and production environments. Handling migrations, RFCs, and post-go-live activities, generating sponsor reports (JReview, SAS, BOXI), acting as DB Coordinator across trials, and mentoring junior team members will also be part of your role. Key Requirements: - 3 to 5 years of hands-on experience with at least one EDC platform such as Medidata RAVE, InForm, Central Designer, or Veeva Studio (combination preferred). - Proficiency in eCRF design, edit checks, dynamic rules, and custom functions (e.g., C# for RAVE). - Solid understanding of clinical trial protocols, DVS interpretation, CDPS/SDV strategy, CRF annotation, and post-go-live activities, including migrations and RFCs. - High attention to detail with strong adherence to ICH GCP and clinical data standards. - Excellent written and verbal communication skills for effective team and sponsor collaboration. - Educational background in BE/B.Tech, M.Sc./MCA, or B.Sc./BCA in Computer Science or a related stream with consistent academic performance of 60% or above in 10th, 12th, and graduation.,

Precision for Medicine is looking for an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. In this role, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans under direct supervision. Your responsibilities will include data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment. The Clinical Data Associate/Senior Clinical Data Associate will provide data management support and assistance in all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. You will follow SOPs/WIs, regulatory directives, study-specific plans, and guidelines. This position may involve database development and testing, as well as additional data management activities. Key responsibilities of the role: - Support the Lead DM as a backup or team member, ensuring continuity, responsiveness, and timely task completion - Perform data entry for paper-CRF studies and ensure quality control of data entry - Provide input into timelines, assess resource needs for projects, and ensure clinical data management deadlines are met with quality - Assist in developing CRF specifications from the clinical study protocol and coordinate review/feedback - Assist in building clinical databases and conduct database build UAT - Specify requirements for edit check types and maintain data management documentation - Train clinical research personnel on study-specific items as needed - Review and query clinical trial data according to the Data Management Plan - Perform medical coding of medical terms for logic and consistency - Assist with coordinating SAE/AE reconciliation and liaising with third-party vendors - Assist with SAS programming and quality control of SAS programs - Identify and troubleshoot operational problems and provide feedback on protocols and reports - Participate in the development and maintenance of SOPs related to data management - Communicate with study sponsors, vendors, and project teams regarding data issues - Present software demonstrations/trainings and participate in project meetings - Perform other assigned duties. Qualifications: - Minimum 4 years of experience in Data Management - Bachelor's degree in a scientific/science field with related experience - Proficiency in Microsoft Office tools - Strong organizational and communication skills - Basic knowledge of drug, device, or biologic development and data management practices Preferred qualifications: - Experience in a clinical, scientific, or healthcare discipline - Medical coding knowledge (MedDRA and WHODrug) - Understanding of CDISC standards - Oncology and/or Orphan Drug therapeutic experience Skills: - Strong knowledge of ICH-GCP, Precision Oncology SOPs, and regulatory guidance Competencies: - Motivates project team members and focuses on continuous improvement - Resolves project-related problems and prioritizes workload effectively - Demonstrates self-motivation and professionalism - Works well independently and in a team environment Precision for Medicine is a precision medicine CRO dedicated to advancing the science of precision medicine across various therapeutic areas. All data provided during the application process will be handled in accordance with the Privacy Policy. Applicants with disabilities requiring accommodations can contact Precision Medicine Group for assistance. Note: Precision for Medicine warns applicants about potential fraudulent offers and emphasizes that all job offers will involve communication with the recruiting team, hiring managers, and a formal interview process.,

About ProcDNA: ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We&aposre a passionate team of 300+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won&apost be stuck in a cubicle - you&aposll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey What we are looking for We are seeking a Programmer Analyst with strong hands-on experience in EDC platforms such as Medidata RAVE, InForm, Central Designer, or Veeva Studio. The ideal candidate will have a solid understanding of clinical data standards, protocol interpretation, and the ability to build high-quality, compliant EDC databases. You will play a key role in supporting the end-to-end development of clinical databases and ensuring data integrity throughout the trial lifecycle. What you will do eCRF & EDC Development: Interpret clinical trial protocols to design eCRFs and build databases using Medidata RAVE, InForm, Central Designer, or Veeva Studio. Configure systems and implement edit checks, dynamic rules, and custom functions (C# for RAVE) based on DVS. Review & Validation: Conduct technical and functional reviews, support Sponsor Acceptance Testing (SAT), and ensure accuracy across all database components. Amendments & Issue Resolution: Manage protocol amendments, metadata updates, lead ICRM/SAM meetings, and resolve issues in QC, UAT, and production environments. Post-Go-Live & Coordination: Handle migrations, RFCs, and post-go-live activities. Generate sponsor reports (JReview, SAS, BOXI), act as DB Coordinator across trials, and mentor junior team members. Must Have EDC Expertise: 3 to 5 years of hands-on experience with at least one EDC platform Medidata RAVE, InForm, Central Designer, or Veeva Studio (combination preferred). Strong skills in eCRF design, edit checks, dynamic rules, and custom functions (e.g., C# for RAVE). Clinical & Technical Knowledge: Solid understanding of clinical trial protocols, DVS interpretation, CDPS/SDV strategy, CRF annotation, and post-go-live activities, including migrations and RFCs. Quality & Communication: High attention to detail with strong adherence to ICH GCP and clinical data standards. Excellent written and verbal communication skills for effective team and sponsor collaboration. Educational Background: BE/B.Tech, M.Sc./MCA, or B.Sc./BCA in Computer Science or a related stream. Consistent academic performance with 60% or above in 10th, 12th, and graduation is mandatory. Show more Show less

The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. You will follow Standard Operating Procedures / Work Instructions (SOPs/WIs), regulatory directives, study specific plans, and guidelines. Your responsibilities include supporting the Lead DM, performing data entry for paper-CRF studies when necessary, conducting quality control of data entry, developing CRF specifications, assisting in building clinical databases, and maintaining quality controlled database build documentation. You will also specify requirements for edit check types, create and revise data management documentation, train clinical research personnel, review and query clinical trial data, run status and metric reporting, perform medical coding, assist in SAE/AE reconciliation, liaise with third-party vendors, and may assist with SAS programming. Additionally, you may identify and troubleshoot operational problems, review and provide feedback on protocols and reports, participate in developing SOPs, communicate with study sponsors, vendors, and project teams, present software demonstrations/trainings, and may require some travel. You should possess a Bachelor's degree or a combination of related experience, have at least 2 years of experience, proficiency in Microsoft Office, excellent organizational and communication skills, and professional use of the English language. Experience in a clinical, scientific, or healthcare discipline is preferred. If you are an individual with a disability and need a reasonable accommodation to complete the application process or require an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. Please be aware of potential fraudulent job offers, and note that our organization follows a formal interview process before extending any job offers.,

5 + years hands on end-to-end Rave study build experience including CRF, edit check, creation of complex custom functions, dynamics/matrix programming, migration planning and execution, and module connections/integrations programming such as Safety Gateway and TSDV. Bachelor s degree required. Ability to work independently with appropriate supervision. Ability to communicate effectively with team members, plan/organize work to deliver against timelines. Attention to detail and programming quality. Ability to identify and resolve problems with appropriate support if needed. Ability to oversee the work of Database Developer I & 2, including training and mentoring. Build studies for initial deployment and protocol amendments and/or oversee CROs and quality check their work (includes forms, database structures, cleaning edit checks). Program study database integrations (TSDV, CCV, TMS, Safety Gateway)Serve as a primary database build point of contact for assigned studies and provide support during study execution and closure. Programming complex custom functions according to best practices. Knowledge of creating Custom function. For database changes after initial deployment perform impact analysis, create test migration plan, execute migration test, and deploy changes into production. Support troubleshooting of technical issues, working with other internal groups and with Medidata as needed. Provide technical support for continuous improvement efforts and audit support (study specific)

Location - Bangalore/Cochin/Kochi/Hyderabad/Karnataka/Kerala/Mysore/Telangana - Understand and follow study start-up, conduct, and close out activities per the standard process, which will be made known to Service Provider and to the Data Manager in advance and in writing by Baxter. - Act as a single point of contact from the Service Provider for the studies as assigned - Prepare/review eCRFs, Edit checks, and Custom Functions requirement document - Prepare or review edit checks requirement and functional test script document - Perform functional testing for eCRF/edit checks and Custom Functions - Identify reports and DM Tables requirements and prepare a report specification document - Review and provide feedback for study conduct activities performed by the Service Provider peer data reviewer as and when required - Train Study Team / Sites on EDC - Perform Query management and manage manual edits checks follow-up messages, etc. - Performing AE reconciliation and preparing material for AE reconciliation meeting and schedule it - Provide inputs to Data Review Plan.

Assess database design requirements relevant to data capture tool, data extraction, processing and reporting. Design database based on protocol and clinical data manager specifications. Make recommendations to management concerning complex technical issues and provide solutions. Configuration and validation of mapping for datasets export from EDC. Program edit checks according to the specifications defined by the clinical data manager. Provide support in the fixing of any issues or required changes to eCRF and Edit Checks encountered during system testing, User Acceptance Testing (UAT) and deployment testing. Import external data in the EDC based on the Data transfer agreement developed in collaboration with the Clinical Data Manager and process. Able to manage multiple studies and projects simultaneously and deliver on the timelines. Able to provide support or manage edit checks testing and UAT if required. Archive study databases and related documents. Participate in the review and development of Quality documents (SOP and working practices). Qualifications Bachelor of Science degree or related field. Experienced EDC / eCRF design developer to deliver an eCRF based on protocol requirements. Knowledge and understanding of clinical research. Significant experience creating eCRFs using any of the eDC tools (egOracle RDC, Lifesphere, Ennov, Inform,). Proven experience in eCRF development with a cross functional study team to meet timelines and deliverables. Experience with data management tools, technologies and processes. Ability to learn new process, programming languages. Additional Information PERSONAL CHARACTERISTICS Eurofins has a culture of high professional standards, with strong processes, and an eye for details. Candidates will need to be fully aligned with this culture, which implies a structured and analytical approach, pragmatism, and modesty.

Experience 4-8 Years of experience in specifications, design, develop and unit test and functionally validate clinical trial setup process edit check specifications and program or modify checks at study level within EDC SME (Subject Matter Expert) for all database related activities Familiar with custom functions within EDC system Prepare, test and implement postproduction changes as per study needs Work with leaders to resolve issues affecting the delivery of clinical trials Lead technology vendor oversight activities Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks

Manager, CSAR - SAS Edit Check Programmer The Manager, CSAR - SAS Edit Check Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Edit check programming activities. The Manager, CSAR - SAS Edit Check Programmer will create and implement edit checks, adhering to Amgen standards, procedures, and best practices using SAS programming. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Edit Check Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related discipline with 9-13 years of experience Proven experience in managing teams Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company). Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena Proven experience in managing teams General project management and planning experience Experience in oversight of outside vendors (CRO, central labs, imaging vendors, IRT vendors, etc.) Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Proficient in SAS edit check programming Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies