4 Veeva Edc Jobs

You have 2 to 3 years of minimum Clinical Data Management experience. You must have exposure to Study Start up, Conduct, and Study Closeout. If you do not have experience in all three phases, you should have good exposure to a minimum of two phases. Hands-on experience with Rave (Medidata) or Veeva EDC is a must. In terms of setup, you should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, and some understanding of UAT (User Acceptance Testing) although it's not mandatory. Your experience in conducting tasks should include Data Cleaning, Query Handling, Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review, among others. You should be familiar with Study Lock activities such as Freezing/Locking and have good experience with Study lock procedures. Having a client-facing role and the ability to mentor others would be advantageous in this position. Your responsibilities will include executing Data Management Activities like Data Cleaning, Manual and System checks, updating relevant trackers, managing discrepancies and queries, resolving issues, and conducting Database lock activities. You will be expected to participate in innovation and process improvement initiatives, and to identify and develop action plans in coordination with the Team Lead for activities not meeting the client SLAs. Furthermore, you will need to archive all necessary information for audit purposes according to quality and security requirements to ensure reliable and timely retrieval of documentation and information. In addition, you will support multiple clinical trials across diverse therapeutic areas and provide technical oversight when required. Having hands-on experience in Study Setup and working exposure in RAVE/VEEVA EDC, as well as knowledge of the Spotfire reporting tool, will be beneficial. Experience in third-party data handling (Lab, PK, Image, etc.), client-facing roles, and effective client communication will also be valuable in this role.,

Clinical Data Manager (Veeva EDC) – 2+ yrs exp in Veeva EDC, UAT (test scripts, edit checks, dynamics), data reconciliation (external/vendor), query management, and SAE reconciliation. Required Candidate profile Must have international BPO exp, life sciences/pharma background. Reject ex-TCS, non-Mumbai/Pune/Bangalore candidates. Graduation mandatory. (9-11 LPA, General Shift).

**Urgent Hiring for the Role of Clinical Systems Specialist Veeva CDMS for our Team** Job Title: Clinical Systems Specialist Veeva CDMS Experience: 8+ years Location: Remote 100% Work Timing: US EST time zone Job Description: - Job Title: Clinical Systems Specialist Veeva CDMS Overview: We are looking for a skilled Clinical Systems Specialist with strong, hands-on experience in Veeva CDMS (EDC) . This role focuses on testing and validation within the Veeva environment and supports various modules in the Veeva CDMS suite. While deep experience with eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms is not required, you should understand how they work within decentralized clinical trials (DCTs) and be comfortable working alongside these systems. Key Responsibilities: Validate workflows within the Veeva EDC module and related components. Apply working knowledge of eCOA and IRT systems to understand clinical data flows and dependencies. Collaborate with clinical operations, data management, and vendors to troubleshoot issues and ensure systems meet requirements. Review data capture logic and perform query testing to maintain data accuracy. Document test results, maintain traceability, and ensure audit-readiness. Help improve validation processes and documentation within the Veeva CDMS environment. Required Qualifications: Strong, hands-on experience with Veeva CDMS , especially the EDC module. Familiarity with eCOA platforms (e.g., Medidata, YPrime, Clinical Ink) and IRT systems (e.g., Almac, 4G, Bioclinica) is a plus. Experience working in decentralized clinical trial (DCT) environments is highly desirable. Solid understanding of regulatory requirements ( 21 CFR Part 11 , GxP ) for clinical systems. Excellent attention to detail with strong documentation and communication skills. Ability to work effectively in cross-functional teams and with external vendors. Note: Interested candidates can drop their resumes at aagnihotri@fcsltd.com

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)