17 Ecrf Jobs

Site Specialist II - India - Office with Flex ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Site Specialist II to join our dynamic team. As a Site Specialist II, you will be responsible for supporting site activation activities, vendor coordination, and documentation processes to enable successful project delivery. This is an excellent opportunity for someone with foundational clinical operations experience looking to advance their career within a global,...

As a Senior Clinical Data Co-ordinator, your role will involve overseeing and co-ordinating tasks delegated to the study team members. You will be responsible for providing training to new data management personnel on data management processes and procedures. Your key responsibilities will include: - Planning, managing, controlling, and performing data processing and management activities for assigned projects in a timely and accurate manner, adhering to trial Sponsors requirements. - Creating and developing study specifications, implementing, testing eCRF or paper CRF edit checks, and conducting data review and overview listings. - Authoring and reviewing the Data Management Plan (DMP) and ...

As a fresher in the field of research and regulatory affairs, you will be responsible for completing appropriate role-specific training to perform job duties. Under supervision, you will assist in various administrative tasks to support team members in project execution. This may include running system reports, maintaining meeting minutes, preparing and distributing status reports, creating and managing study documents, and more. - Assist in various administrative tasks to support team members in project execution - Run system reports, maintain meeting minutes, prepare and distribute status reports - Create and manage study documents Your role will also involve updating and maintaining syste...

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical...

As a Senior Clinical Data Co-ordinator, you will be the primary point of contact for data management activities related to the study. Your responsibilities will include overseeing and coordinating tasks assigned to the study team members, providing training to new data management personnel, and planning, managing, and performing data processing and management activities for assigned projects. Key tasks will involve creating and developing study specifications, implementing and testing eCRF or paper CRF edit checks, authoring and reviewing the Data Management Plan (DMP), designing and reviewing case report forms (CRFs/eCRFs), and participating in the database design process including User Acc...

6-8 years of experience in Clinical Data Management/Clinical Data base programming or relevant field. Location: Mumbai Pune, Bangalore, Hyderabad, Kolkata Good technical experience on EDC systems (Rave/Veeva) Ability to provide technical expertise. Proactively communicate ownership of studies. Critical thinking to identify root causes and best practices. Knowledge of create high quality EDC specification. Knowledge of both SDTM and C-DASH (Clinical Data Acquisition Standards Harmonization) Knowledgeable of study protocols and create specifications that align to key deliverables. Knowledge of creation of Edit check specification and knowledge of programming edit check Knowledge of EDC design ...

Responsibilities: * Collaborate with cross-functional teams on system design and implementation. * Develop EDC systems using Medidata Rave software. * Conduct UAT testing per GCP/GDP guidelines.

Position Summary: The Clinical Data Manager II is responsible for providing expert skills as part of the clinical data management team within the Data Management and Statistics Department to ensure that efficient and quality data management products are produced in accordance with customer requirements. The Clinical Data Manager II is able to assist and lead data management team and provide support to Lead Clinical Data Manager, develop project documentation, project plans, EDC system setup, data review and validation processes. Role & responsibilities Implements, monitors and supervises data management activities within assigned clinical trials, i.e., is responsible to design, create, valid...

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 E...

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 E...

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical...

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

Hi We are looking to hire Medical Data Reviewer for our Client. Please go through the JD and Apply. Responsibilities: Review subject/ patient level data for accuracy, to identify any anomalies, trends in patient reported data Review and provide inputs ion design of eCRF Review investigation product dosing Review all reported Adverse Events (AEs), Concomitant Medication and medical Ensure that any out of range data/ anomaly is verified Review all laboratory data on study subjects Review data in the form of visualizations and identify potential issues of concern Training new team members Qualifications: Bachelor/ Masters degree or equivalent in Life sciences/ Alternative Medicine (preferred) E...

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

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

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

- 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...