36 Edc Systems Jobs

Work Schedule Second Shift (Afternoons) Environmental Conditions Office Works with and has hands on experience of clinical data management systems like Medidata Rave & Veeva Vault and provides technical leadership in data management activities and deliverables including, but not limited to, database development and data validation. Serves as the lead programmer on selected studies of moderate complexity, working directly with project team leaders and client representatives to assess and develop project goals and timelines. Assumes leadership responsibility as a contributing member of a multi-disciplinary clinical trials project team, communicating actively and frequently with other team memb...

Working at Bristol Myers Squibb is not just a job, it is a unique and challenging opportunity where you can make a meaningful impact on the lives of patients and your own career. You will be part of a dynamic environment where interesting work takes place every day across all departments. Whether you are optimizing a production line or contributing to the latest breakthroughs in cell therapy, your work at Bristol Myers Squibb will be transformative. You will have the chance to grow and thrive through exceptional opportunities alongside high-achieving teams, taking your career to new heights. As part of the team at Bristol Myers Squibb, you will have responsibilities that include, but are not...

As the Lead Data Manager, your role involves overseeing end-to-end clinical data management activities for multiple trials to ensure data integrity, protocol compliance, and timely database deliverables. You will provide technical leadership, manage data systems and processes, and collaborate with study teams throughout the study lifecycle. Key Responsibilities: - Execute and oversee data management activities for multiple clinical trials, ensuring accuracy and alignment with protocols and EDC systems. - Apply advanced understanding of clinical development, CDISC standards (CDASH, SDTM), technical platforms, confidentiality protocols, and project management principles. - Contribute to trial ...

As a Clinical Data Manager at Statistics & Data Corporation (SDC), your role will involve participating in all data management activities to support clinical and/or non-clinical research studies. You will work closely with lead Clinical Data Managers and/or Clinical Data Analysts to manage project activities throughout the lifecycle of the projects. Your primary responsibilities will include: - Independently performing study setup activities such as CRF design, database structure design, annotation, DMP, CRF completion guidelines, and data entry screen design - Serving as a primary or backup resource for data management issues - Assisting with management of timelines and communication relate...

As a Senior Clinical Data Manager I at Allucent, your role involves leading data management activities in the Allucent Data Management (DM) department. You will be responsible for managing, coordinating, reviewing, and approving DM deliverables from database design & set-up to database locking. It is crucial to ensure the completeness, accuracy, and consistency of clinical data to meet quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas, participate in cross-functional initiatives, and contribute to the development of departmental processes, tools, and staff training. Your involvement in Request ...

Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Database Designer to join our Biometrics team. This position will work in a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities Maintain eCRF and Edit Check Specification standard templates according to CDISC standards for data collection and data submission; Develop and maintain eCRF specifications on a study-by-study basis (e.g., reviewing protocol and customize library eCRFs to ...

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: Participates in all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout working closely with the lead Clinical Data Manager(s) and/or Clinical Data Analyst(s). Manages t...

Overview The Principal Medical Coder is responsible for overseeing centralized medical coding / SAE activities and managing a team of Medical Coders. Highly proficient and detail-oriented specializing in accurately coding complex medical data from clinical trials, ensuring compliance with regulatory standards and industry guidelines. Acts as MedDRA and WHODrug SME for coding teams and cross functional study team stakeholders. Adept at collaborating with clinical and data management teams to streamline coding processes and improve operational efficiency. Committed to continuous professional development and staying current with evolving medical terminologies and coding systems to maintain the ...

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 in support of the overall project. - Managing communication throughout the team and stakeholders. - Leading product implementation efforts by coordinating with customers, product SME, and other teams. - Managing the quality of Implementation deliverables. - Documenting and reporting status on Risks, Issues, Actions, and Decisions. - Identifying, reporting, and managing risks; overcoming project obstacles. - Acting as a client liaison and representative by c...

As an Implementation Consultant at our company, your role will involve the following key responsibilities: - Responsible for creating User Requirement Specifications (URS) and functional requirement specs in Clinical Reporting and Analytics. - Create wire-frames and mock-ups for Clinical reports. - Communicate with Clinical Data Management & Medical Reviewers to document the clinical reporting needs. - Stay up-to-date with all Saama product features and releases. - Analyze and understand current business processes, events, and flows in Clinical Trial Development. - Act as a Clinical Subject Matter Expert and provide Clinical Project Support. - Author and document business requirements, provi...

CDC I - Bangalore India 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 Clinical Data Coordinator I to join our diverse and dynamic team. As a Clinical Data Coordinator at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What You Will Be Doing? Assist Data Management Study Lead in development of eCRF, Data Validation S...

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...