25 Edc Systems Jobs

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...

Job Title: Clinical Quality Compliance Manager Location: Bengaluru, Karnataka, India Reports To: QA/Compliance Director or Clinical Operations Director Job Summary: Clinical Site Auditor to ensure compliance and quality at Clinical Trial sites. You will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP and regulatory requirements. Key Responsibilities: Conduct audits of clinical research sites across phases IIV. Review CRFs, informed consent forms, and regulatory documents. Identify and report audit findings; recommend corrective actions. Support site staff with compliance guidance and training. Prepare audit reports and follow up on CAPA implementation. ...

Job title : Team Lead - Registry Projects ( Regional Project Lead) Hiring Manager: Group Lead Study Management Location: Hyderabad % of travel expected: Travel required as per business need Job type: Permanent and Full time About The Job Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions . Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. The Sanofi Business Operations is buil...

Job Description JOB TITLE Project Manager REPORTING TO Nikita Bathla LOCATION New Delhi/Remote OPEN ENDED / FIXED TERM (Duration) Two-year appointment, extendable based on performance and institutional opportunities. FULLTIME EQUIVALENT 2.0 JOB FAMILY Projects CAREER STEP Independent About The George Institute We are a medical research institute affiliated with leading universities aiming to challenge the status quo in health care. With 700+ people around the world, and projects in over 40 countries, our Strategy 2025 is all about impact - specifically, the impact of The George Institute's activities on the health of millions of people, particularly those living in disadvantaged circumstance...

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Lead in the evaluation, implementation, and validation of packaged systems. Create, maintain, and oversee processes for providing end user support in EDC systems. Build studies and support other users to build studies in EDC and other GxP systems. Works as par...

As a Senior Clinical Data Manager I at Allucent, you will be responsible for leading various data management activities within the Data Management (DM) department. Your role will involve managing data deliverables from database design to locking, ensuring the quality and completeness of clinical data meet regulatory requirements. Additionally, you will provide expertise in data management areas, develop departmental processes, and support in Request for Proposals (RFPs). Your key responsibilities will include: - Being the primary contact for data management with internal and external parties - Planning and allocating required resources, managing tasks, timelines, and quality - Developing and...

As a Data Coordinator at Medpace, you will be part of the Data Management team based in India, Mumbai. Your primary responsibility will be to track and maintain metrics of data within EDC systems, clean the clinical database, reconcile clinical data, and assist with support activities for the Data Management department. Key Responsibilities: - Track and maintain metrics regarding the status of data within EDC systems - Clean the clinical database, including generating and resolving data clarifications - Reconcile clinical data - Assist with support activities for the Data Management department Qualifications: - Bachelor's degree in life science/pharmacy/health-related field with strong atten...

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...

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must H...

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must H...

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must H...

About the Role Role Description: The Manager will support the oversight of Rave EDC user access and management of Classic Rave and Rave EDC system upgrades for all Rave URLs. This role involves coordinating cross-functional activities to manage the Rave EDC Platform effectively. It requires a highly organized, proactive , and detail-oriented professional capable of managing multiple projects and meeting timelines. Roles & Responsibilities Technical Support / Project Coordination: Provide support for clinical trial platform technologies related to the Rave EDC System Work with the EDC vendor to translate business issues/requirements into technical solutions Manage Rave EDC FMT meetings , incl...

As an Implementation Consultant reporting to the Product Owner, your key responsibilities will include creating User Requirement Specifications (URS) and functional requirement specs in Clinical Reporting and Analytics. You will be tasked with developing wireframes and mock-ups for clinical reports, as well as communicating with Clinical Data Management & Medical Reviewers to document clinical reporting needs. It is essential that you stay up-to-date with all Saama product features and releases. Your role will involve analyzing and understanding current business processes, events, and flows in Clinical Trial Development. You will act as a Clinical Subject Matter Expert, providing support for...

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include guiding the client through release planning, managing communication throughout the team and stakeholders, leading product implementation efforts, coordinating with customers, product SME, and other teams, managing the quality of implementation deliverables, and documenting and reporting status on Risks, Issues, Actions, and Decisions. You will need to identify, report, and manage risks while overcoming project obstacles. Acting as a client liaison and representative, you will communicate client feedback...

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. We are seeking a dynamic Manager to join our Life Sciences Consulting team, specializing in Clinical Operations transformation. This role involves working with global pharmaceutical, biotech, and medtech clients to optimize R&D and clinical delivery models, streamline operations, and implement emerging technologies across clinical developmen...

You should have at least 2 years of experience in Clinical Trial EDC, preferably with systems like Veeva, RAVE, or Oracle, and/or Reporting experience, preferably with tools like JReview, Spotfire, Jupyter Labs, or SQL. You should be familiar with common troubleshooting tools and technologies such as JIRA, Dynamics, and have a good understanding of Microsoft Office products like Office, Excel, PowerPoint, and Dynamics. It would be ideal if you have an understanding of web technologies and web services like RESTful APIs, SOAP, and experience with database technologies such as Java, Python, and SQL, for troubleshooting issues related to cloud-based software systems. In addition to technical sk...

Are you ready to make a significant impact in the world of Biopharma Clinical Operations As an Associate Director in GCS Business Technology Solutions, you'll be at the forefront of driving industry-leading processes, technology, and services. Your role will be pivotal in owning the lifecycle management and continuous improvement of specific clinical operations processes, systems, or services. Collaborate with internal and external stakeholders to ensure customer needs are met and optimize the delivery of clinical studies. You'll identify and deliver improvements using tools like Lean Six Sigma to improve clinical study delivery. Are you up for the challenge Design, develop, implement, maint...

As the EDC Systems Specialist, your primary responsibility will be to design eCRF layouts and databases in alignment with EDC systems. You will be tasked with setting up core configurations in Medidata Rave or other EDC platforms. It is mandatory for you to implement dynamic rules and custom functions using C# as per sponsor requirements. Additionally, you will create, test, and maintain edit checks based on Data Validation Specifications. Your role will involve incorporating internal feedback and SAT feedback from sponsors to enhance the eCRFs and components for protocol amendments and metadata updates. You will perform a second/final peer review of deliverables to ensure accuracy and compl...

At EY, you will have the opportunity to shape your future with confidence, succeed in a globally connected powerhouse of diverse teams, and take your career wherever you desire. Join EY to help build a better working world. As a Data Integration Architect with 8+ years of experience in clinical or life sciences domains, you will lead the integration of Medidata platforms into enterprise clinical trial systems. Your role will involve designing scalable, compliant data integration solutions, collaborating across global R&D systems, and contributing to data-driven innovation in the healthcare and life sciences space. You will play a crucial part in aligning integration efforts with organization...

As a Manager in GCS Business Technology Solutions at AstraZeneca, you will play a crucial role in leading and innovating in the realm of Biopharma Clinical Operations. Your primary responsibility will be to design, develop, and continuously improve processes, systems, and services that drive clinical study delivery. You will collaborate with internal and external stakeholders to meet customer needs and enhance the efficiency of clinical studies. Utilizing tools like Lean Six Sigma, you will identify and implement improvements to ensure optimal end-to-end delivery. Are you ready to make a difference in this dynamic and challenging role Your key accountabilities will include designing, develop...

The Clinical Data Manager is responsible for overseeing all data management activities pertaining to the conduct of Phase I-IV clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met. Participate as the primary data management representative on the QED multidisciplinary project teams and as the primary point of contact for all data management interactions with the Sponsor. Participate in protocol developments and review, in review of clinical study reports and statistical analysis plan, in the development of data dictionaries complete with variabl...

You will be responsible for creating a catalogue of reports to support data cleaning activities with low to medium complexity. Your tasks will include automating manual checks, reconciliation, and program edit checks for TPV data to ensure quality. Additionally, you will develop tools and repositories to minimize data errors at the source for the collection of lab reference ranges. You will program reports to identify missing pages, detect errors at the Subject level, and create reports to measure metrics for assessing data cleaning status. Furthermore, you will be tasked with creating visualizations and dashboards to identify discrepancies and trends in EDC and TPV data. In addition to the ...

As a Clinical Database Programmer at ProcDNA, you will play a crucial role in designing the eCRF layout and corresponding database, implementing dynamic rules based on Sponsor requirements, and creating trial-specific Edit Checks. Your responsibilities will also include developing Custom Functions using C# for Rave studies or other EDC systems, incorporating internal and Sponsor feedback, and maintaining eCRFs and components as per protocol amendments or metadata updates. Additionally, you will support CRO trial activities, create reports using JReview, SAS, BOXI, and handle migration processes for Post Go-Live studies. To excel in this role, you must have a deep understanding of Clinical Pr...

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 Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing tech...

Manager, CSAR - Electronic Data Interchange and Acquisition Role Description The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical Reporting, focusing on Electronic Data Interchange/Acquisition programming activities. This role involves developing the Data Acquisition Requirements Specification (DARS) document to outline metadata transfer requirements, establish and validate vendor integration criteria, and manage the processing of electronic data from vendors. The position requires cross-functional collaboration to ensure high-quality deliverables, support clinical systems, and oversee electronic data capture technolog...