21 Edit Checks Jobs

As the clinical database and data management subject matter expert on Clinical Project Teams, your role involves the following key responsibilities: - Attend Clinical Project Team meetings to gather business need requirements and translate them into technical requirements - Partner with other shared service functions like Safety, Core Lab, etc. to gather business need requirements and translate them into technical requirements - Identify, analyze, propose solutions, and effectively resolve complex data issues by collaborating with the clinical project team members and other shared service functions - Train database End Users (internal and external users) on the database and/or maintain autom...

JOB DESCRIPTION: Represents Data Management as the clinical database and data management subject matter expert on Clinical Project Teams through the following: . Attend Clinical Project Team meetings to gather business need requirements and translate to technical requirements . Partner with other shared service functions such as Safety, Core Lab, etc. to gather business need requirements and translate to technical requirements . Identify, analyze, propose solutions, and effectively resolve complex data issues by exercising appropriate judgment and collaborating with the clinical project team members and other shared service functions . Train database End Users (internal and external users) o...

What We Are Looking For We are seeking an experienced Clinical Data Manager (CDM) / Lead Clinical Data Manager to joinour growing clinical data management team. The ideal candidate will have a strong background inend-to-end data management, EDC systems (preferably Medidata Rave, Veeva, InForm/CD orsimilar), and experience leading or mentoring data management teams. This role will be office-based in Gurugram, with close collaboration with leadership and cross-functional teams to ensuredata integrity, compliance, and quality throughout clinical studies. What You'll Do Manage and oversee all aspects of clinical data management (CDM) activities for assigned clinicalstudies. Develop and review Da...

Roles & Responsibility Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. • Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. • Serves on project teams to coordinate and lead development a...

As a Clinical DB Designer, your role involves conducting testing activities in CDMS environment to produce efficient, quality databases that meet customer requirements. Your key responsibilities include: - Independently validating edit checks, system settings, SAS listings, Transfer Programming, and custom reports in platforms like InForm, RAVE, OCRDC. - Having a solid understanding of database structure. - Ensuring strict adherence to validation processes and best practice guidelines by yourself and the team. - Updating all relevant documentation in a timely manner and communicating project status to Validation Team Lead/Manager. - Mentoring Associate Validation Analysts in testing activiti...

As a Senior Clinical Data Associate at [Company], you will be responsible for providing data management support and assistance throughout the clinical trial data management process. Your role will involve following Standard Operating Procedures (SOPs) and regulatory directives to ensure the successful completion of assigned projects. Some key responsibilities include: - Supporting the Lead DM as a back-up and/or team member to ensure tasks are performed in a timely manner - Performing data entry for paper-CRF studies and conducting quality control of data entry - Assisting in developing CRF specifications and coordinating the review/feedback from stakeholders - Building clinical databases an...

As a Clinical Data Management (CDM) Executive at our company, your role will involve working closely with client study teams to design and configure user-friendly CRFs/eCRFs in EDC/CDM Systems. Your responsibilities will include preparing and reviewing validation logic, edit checks, and system rules to maintain data quality, as well as performing structured User Acceptance Testing (UAT) for databases and forms. You will also be expected to participate in functional and user acceptance testing of our in-house EDC system, validate edit checks and data integrity, and create and execute test cases to ensure compliance with system requirements and regulatory guidelines. Key Responsibilities: - Co...

The Clinical Data Associate II role involves providing data management support for clinical trial projects from study initiation to post-database lock, while adhering to SOPs, regulatory guidelines, and study-specific plans. Your responsibilities include supporting the Lead DM, performing data entry, quality control, developing CRF specifications, building and testing clinical databases, and maintaining data management documentation. You will also be involved in training clinical research personnel, reviewing and querying trial data, conducting medical coding, and assisting with various data-related activities such as SAE/AE reconciliation and vendor coordination. Additionally, you may contr...

Designation: Clinical Data Management Full Time Opportunity Location: Multiple Job Description: - 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 specificatio...

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 understandin...

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 manageme...

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...

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 fo...

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 dep...

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 - Revie...

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 c...

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 respon...

- 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 P...

- 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 P...

- 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 P...