4 Rave Edc Jobs

Create and execute test plans/UAT scripts for EDC system (Veeva CDMS/Rave EDC). Ensure build quality, validate integrations, document result, and collaborate cross-functionally. Expertise in clinical data system, Agile methodologies, software testing

Study Designer and Edit Check Programmer We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture (EDC) technology. We are seeking a strong leader who can confidently influence stakeholders and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to: 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 systems and compliance with established procedures/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 reduce database development cycle time and foster a collaborative working environment Providing technical and business process input/expertise on new and emerging technologies Develop, review, and implement policies, SOPs, and associated documents Ensure documentation supports CSAR operational or technical activities in a complete manner, consistent with regulatory and established processes Assist in preparing for and responding to audit findings (internal or external) Knowledge Areas: Good Clinical Practice Strong understanding and experience in performance management techniques, measures, problem-solving, and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Edit check development and custom function programming Programming languages Systems development lifecycle (SDLC) Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and risk analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications: Advanced degree or equivalent in life science, computer science, math, statistics, business administration, or related discipline Broad knowledge/work experience in data management/programming in the pharmaceutical or biotech sector General project management and planning experience Experience in oversight of external vendors (CROs, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications: Bachelor's degree or equivalent in life science, computer science, business administration, or related discipline with 9 to 12 years of experience Specialist knowledge/experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical, or CRO company)

The Manager will support the oversight of the Rave EDC user access and management of the Classic Rave and Rave EDC system upgrades for all Rave URLs. Coordinate the cross functional activities to manage the Rave EDC Platform. This role requires a highly organized, proactive and detail-oriented professional to manage and execute these activities. Ability to manage multiple projects and meet the timelines. Roles & Responsibilities: Technical Support/Project Coordination: Support of clinical trial platform technologies for the Rave EDC System Ability to work with the EDC Vendor on translating business issues/requirements into technical solutions Manage the Rave EDC FMT meetings, agenda, meeting minutes, etc. Coordinate and provide oversight of the Rave User Access for all studies for all Rave URLs Potential evaluation of other EDC systems, e.g. Veeva System etc. Maintain standard business processes within GDO Systems to ensure compliance to regulatory bodies Coordinate the activities with the 3rd party vendor team for all Rave upgrades and custom script validation Coordinate the cross functional teams for testing activities for all impacted downstream systems for Classic Rave and Rave EDC releases Act as a liaison between Rave R & D stakeholders related to all systems used for the Rave access related to design of new functionality based on changes in the business or regulatory agencies Act as a technical point of contact to work with DTI team to manage enhancements to systems used by R&D stakeholders, e.g. STAR, DMP, etc. Provide technical and business process input / expertise for adoption of automation and/or new technologies for existing systems Manage all document creation and/or updates to documents related to Rave User access including acquisitions, e.g. Horizon Ability to evaluate and conduct risk assessment for potential other EDC systems, e.g. Veeva System etc. Confidentiality & Professionalism: Handle sensitive and confidential information with utmost discretion Act as a gatekeeper to ensure alignment with the executives priorities Basic Qualifications and Experience: Masters degree and 4 to 6 years of related experience Bachelors degree and 6 to 8 years of related experience Diploma and 10 to 12 years of related experience Functional Skills: Management and operational oversight of GDO system, platforms and tools (e.g., EDC) Ensure quality and timely operational delivery of systems activities supporting EDC platform upgrades Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting GDO Continuous improvement of processes for the Rave User access and EDC release validation Continuous optimization and streamlining of the Rave EDC Release validation including the implementation of new AI /Automated processes Ability to assist R&D Stakeholders inquiries regarding Rave User Access and managing the EDC mailbox Must-Have Skills: Strong technical and analytical skills with the ability to manage multiple projects Exceptional attention to detail and accuracy in all deliverables Ability to work independently and proactively in a fast-paced environment Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx) Good-to-Have Skills: Knowledge of pharmaceutical industry terminology Experience working in a multinational environment with global teams Familiarity with project management tools and methodologies Basic understanding of compliance and data privacy requirements Soft Skills: Excellent verbal and written communication skills High degree of professionalism and interpersonal skills Strong problem-solving abilities and adaptability to changing priorities Resilience, discretion, and the ability to thrive under pressure

Greetings from HCL! Currently Hiring for "Medidata Rave" Skill Medidata Rave Rave EDC Rave Coder + Argus Any PV tool Pharma, Life Science Experience - 4-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Candidate Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda.baby@hcltech.com