6 Ecrf Design 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.,

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

Excelya is a leading independent Contract Research Organization (CRO) in Europe, dedicated to providing a people-centered approach since its inception in 2014. As a part of the ambitious health company, with a team of 900 Excelyates, our unique service model offers a diverse array of projects, enabling professional growth and personal development. In collaboration with experts, Excelya aims to advance scientific knowledge and enhance the patient journey, striving to become the clinical research leader in Europe. As a Clinical Data Manager at Excelya, you will be responsible for executing Data Management tasks in compliance with regulatory standards and Client SOPs. Working under the supervision of senior staff, you will be involved in data cleaning, review, discrepancy management, and reconciliation activities on assigned studies. Additionally, you will collaborate with the Lead Data Manager, generate study metrics and reports, and participate in study documentation archiving. Excelya is currently seeking a Full Service Provider role of Clinical Data Manager I (CDMI) based in Bangalore, India. The role requires a candidate with a Bachelor's degree in a Scientific discipline, preferably with at least one year of experience as a Data Manager or relevant expertise. Knowledge of ICH GCP guidelines, clinical trial databases, data flow, and proficiency in office computer applications are essential requirements for this position. Effective communication skills, both verbal and written, along with a commitment to professionalism, ethics, and compliance, are key attributes we are looking for in potential candidates. The successful candidate for the role of Clinical Data Manager at Excelya should be fluent in both the local language and English. This full-time position is located in Bangalore and offers an opportunity to contribute to the field of Clinical Research. If you are passionate about making a difference in the healthcare industry and meet the mentioned requirements, we encourage you to apply for this exciting opportunity. If you are interested in this position, please reach out to Bhavya Reddy, HR Manager, for further details.,

Interprets the study protocol. Design and update the eCRF. Create and update Edit Specification Document. Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page) Complete the Study Authorization Form and Trial Capacity Request Form (InForm) Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document. Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates. Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan. Escalate potential quality issues. Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures. Reviews build timelines and provide input as applicable. All responsibilities are essential job functions unless noted as nonessential (N). Qualifications Bachelors Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req

Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective. Essential Functions Interprets the study protocol. Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable. Create and update Edit Specification Document. Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page) Complete the Study Authorization Form and Trial Capacity Request Form (InForm) Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. May lead Online Screen Review Meeting. Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document. Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates. Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan. Escalate potential quality issues. Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures. Reviews build timelines and provide input as applicable. Reviews QIP for own projects, identify out of scope activities if any and inform relevant parties. Responsible for multiple study design projects at the same time. Might be working on projects across multiple platforms. Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes. All responsibilities are essential job functions unless noted as nonessential (N). Qualifications Bachelors Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req 2-4 years of relevant core Technical designer experience and total exp being 7+ yrs. Req

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.