252 Veeva Vault Jobs - Page 3

Team Leadership & Oversight Support and mentor a team of Clinical Data Specialists, promoting consistency, quality, and productivity. Collaborate on training plans, performance goals, and team development. Provide day-to-day guidance and technical support related to data issues. Help manage team capacity, workload distribution, and scheduling across studies. Foster effective collaboration with cross-functional teams. Data Management & Quality Assurance Accurate data maintenance, quality control, and discrepancy resolution in CTMS and EDC systems (e.g., RAVE, Veeva Vault, Clinical One, Inform). Review source documents for adherence to ALCOA-C principles and regulatory guidelines (GCP, HIPAA, ...

Position Overview We are seeking an experienced Clinical Data Specialist II to join our clinical research team in Chennai. The successful candidate will be responsible for accurate and timely data entry into Electronic Data Capture (EDC) systems from various e-source documents, including real-time data and Clinical Research Information Officer (CRIO) sources. Key Responsibilities Data Management Perform accurate data entry into EDC systems from e-source documents (Real-time & CRIO). Conduct data verification and validation to ensure data integrity. Execute data reconciliation activities between different data sources & EDC. Maintain detailed logs of data entry activities and progress trackin...

Set up EDC studies in Vault CDMS using Studio. Configure study design elements (forms, edit checks, rules, and custom coding). Collaborate with clinical and data management teams to support study build and go-live Perform user acceptance testing (UAT) and support data cleaning and issue resolution. Manage change requests, configuration, and enhancements in Vault application Knowledge of Vault APIs, data migration Assess the impact for periodic upgrades and support on implementing all upgraded features. All vault modules get upgraded with new releases 3 times a year. Experience with supporting ticketing systems like ServiceNow, Jira, etc. Experience in working on L2 support. Experience in ITI...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Veeva Vault CDMS Location: [Hyderabad, Bangalore, Pune, Mumbai] Experience Required: 3 to 8 years Notice Period: immediate to 7Days Job Description: Veeva Vault CDMS (Clinical Data Management System) Key Responsibilities: Strong Understanding of Clinical trail processes, GCP, and EDC system workflows Familiarity with Vault CDMS architecture, object configuration and User roles Set up EDC studies in Vault CDMS using Studio. Configure study design elements (forms, edit checks, rules, and custom coding). Collaborate with clinical and data management teams to support study build and go-live Perform user acceptance testing (UAT) and support data cleaning and issue resolution. Manage change reques...

Our Team Brief introduction of the department, team, purpose, and missions. Highlight what is unique to your team. Sanofi Business Operations Medical & Commercial (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. SBO strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally. Main Responsibilities The overall purpose and main responsibilities are listed below: Design and develop web-based components in Veeva Vault, HTML5, CSS and JavaScript from t...

Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecy...

As a Project Manager for Content analysis in the Commercial, GBS department at Novo Nordisk, you will be responsible for interpreting data on content usage across digital channels, reporting important KPIs and content performance, and driving a data-driven approach in the internal content production hub. Your role will involve: - Acting as an expert in analytics of content usage by analyzing data and providing insights to global and local teams. - Developing a data-driven agenda to ensure actionable insights that can drive business change. - Serving as a sparring partner to relevant functions on a global and local level to improve content use and re-use. - Ensuring high-quality reporting fou...

Hiring for Narrative Writer-Mumbai,Pune Any Grad/PG with 5 to 10yrs in Narrative Writing in Clinical Documents, Protocols,Clinical Study Report,Narratives,Clinical StudyPharmacology Report. Salary-max 18 LPA Call Suhani-9911988552 Rukhsar-9899875055 Required Candidate profile -MW1-Clinical documents, Protocols, Clinical Study Pharmacology Report,CSR, Regulatory Affairs, Regulatory Publishing, eCTD, NEES, Docubridge. -MW2- xEVMPD, OMS,IDMP, RIM, Veeva Vault.

As a Quality Management System (QMS) Specialist, your role will involve establishing, implementing, and continuously improving the company's QMS to support its clinical-stage biopharmaceutical development programs while ensuring compliance with regulatory requirements such as FDA, EMA, ICH, and GxP standards like GMP, GDP, GCP, GLP. Your responsibilities will include: - **QMS Development & Implementation**: - Developing, implementing, and maintaining a phase-appropriate QMS aligned with regulatory requirements. - Establishing, reviewing, and updating Quality System documentation to support GxP operations. - Serving as the system owner for the electronic QMS and ensuring effective document co...

About Us: Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Role Description: The Scientific Communications Associate Project Manager (APM) provides project management support across the Scientific Communications portfolioincluding publications, medical content, and congress deliverablesin alignment with business p...

Site Name: Bengaluru Luxor North Tower Posted Date: Nov 7 2025 Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. We're uniting science, technology, and talent to get ...

Job Description for a Medical Communications Writer The ideal candidate must have a strong background in medical and scientific writing, especially the medico-marketing/marketing communications. He/she must have a deep understanding of the pharmaceutical, life-sciences, medical devices and healthcare industry, and the ability to understand complex information and create a clear and an engaging content. As a Medical Communications Content Writer, he/she will play a critical role in our efforts to deliver high-quality communication materials that support our clients goals. Key Responsibilities : Content Development: Ability to read and understand the project brief, guide the content writers an...

Work Schedule Second Shift (Afternoons) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards The Senior Clinical Data Associate (Sr CDA) position at Trialmed (a global site network and the early phase clinical solution for PPD, the clinical research business of Thermo Fisher Scientific Inc.) offers an exceptional opportunity to work with a global team and lead world-class data management projects that drive scientific research forward. As a Sr CDA, you will serve as the supporting data manager for one or more projects, emphasizing flawless execution and strict adherence to project protocols. Key responsibilities Supports the setup of study activities ...

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards The Senior Clinical Data Associate (Sr CDA) position at Trialmed (a global site network and the early phase clinical solution for PPD, the clinical research business of Thermo Fisher Scientific Inc.) offers an exceptional opportunity to work with a global team and lead world-class data management projects that drive scientific research forward. As a Sr CDA, you will serve as the supporting data manager for one or more projects, emphasizing flawless execution and strict adherence to project protocols. Key responsibilities Supports the setup of study activities such as...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Responsibilities: * Manage Veeva Quality Vault environment * Ensure compliance with regulatory requirements * Collaborate on quality system implementation and maintenance * Oversee document control processes

As a Veeva QMS Solution Architect at Cyient, you will be responsible for developing and maintaining solution architecture, system administration, security, and procedures across the Veeva Vault Platform. Your key responsibilities will include: - Supporting all assigned development activities for the Veeva Vault implementation program under the leadership of the client Quality Veeva team. - Coordinating with Business analysts to outline the business requirements and ensure IT security and Data Integrity requirements are outlined for the solution. - Coordinating with Validation team to prepare the Regulatory Applicability Assessment and Regulatory Risk Assessment documents. - Documenting speci...

As a Clinical Supply Chain Support Specialist at Capgemini, your role involves providing operational support to Clinical Supply Chain Study Leaders for multiple studies across all phases (set-up, follow-up, closure). You will work independently and collaborate with cross-functional teams to ensure smooth supply chain operations and compliance with regulatory standards. Your responsibilities will include: - Prepare and track transfer orders. - Manage stock reconciliation and monitor destruction needs. - Perform quality checks and maintain inspection readiness. - Prepare documentation for labeling and shipments. - Archive documents in the electronic Trial Master File. - Communicate effectively...

Role Overview: As a GBS TMF Co-Ordinator (eTMF-electronic Trial Master File Coordinator) at our Bangalore location, you will provide day-to-day support for the preparation and management of TMF documents before uploading and indexing in the eTMF system. Your role is crucial in ensuring the accuracy and completeness of clinical documentation, contributing to inspection-readiness and compliance with global regulatory requirements. You will work collaboratively with clinical project teams to support smooth TMF operations. Additionally, you will be responsible for managing and maintaining the AZ study-specific TMF index, including EDL updates and records management in the eTMF platform. Your rol...

Job Description The Regulatory Data & Systems Manager will be responsible for facilitating system administration tasks and interpreting requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves managing and optimizing complex systems, ensuring compliance with regulatory regulations and guidance, and facilitating effective communication between various departments involved in the submission process. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs, and project management. Roles & Responsibilities: System Administration: Manage and maintain the organization's IT systems, ensuring they...

JD:- Must Have Senior Associate Scientific Writing 1. Working with clients & PM team to understand the project requirements, create content plan for the deliverable as per the target audience & objective, provide solution for queries and work with internal cross-functional teams and providing directions to graphic designing team in developing the creative elements such as images/visuals/interactivities/animations. 2. Understand the structure and flow of content to re-organize the same for further use, as required. 3. Developing & reviewing the scientific content for promotional literature and medico-marketing solutions such as promotional emails, patient/physician brochures, newsletters, pro...

Seeking a CSV Engineer to lead validation of LabVantage LIMS 8.7Hamilton integration via Scitara DLX , using Kneat Gx for lifecycle management. Ensure GxP/21 CFR Part 11 compliance, collaborating with QC, QA, IT, and vendors .

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a TMF Specialist to join our A-team. The TMF Specialist I coordinates the indexing of documents within the Trial Master File at Allucent. This position controls and monitors the quality of documents filed in the TMF and completes the approval step for documents. In this roleyour key tasks will include: Reviews documents for compliance with Good Document Practices and ALCOA+ standards. Reviews the categorization of documents to confirm that they are filed in accordan...

JOB DESCRIPTION Job title Manager / Sr Manager- Veeva Vault Configuration and Admin (IT-QA) Reports to Operations Head Job purpose Focus: Technical configuration and system integration across Vault modules Document management and system administration (Quality Docs / EDMS) Core Function: Configure Vault to meet business needs and ensure system validation. Ensure controlled documents are accurate, compliant, and accessible. Job Location: Hyderabad, India. Key Responsibilities Administer and maintain Veeva Vault DMS (Quality Docs or equivalent). Configure Vault modules (Quality Docs, QMS, RIM, Promo Mats, eTMF). Oversee document lifecycle - creation to archiving - per GxP and quality standards...