9 Cdash Jobs

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 Senior Clinical Data Manager I to join our A-team. The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.?? This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. Position provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings. **This position is for the Bengaluru Location and not home-based** In this roleyour key tasks will include: Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites). Plan and project the resources required including management of tasks, timelines, risk and quality. Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition. Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements. Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements. Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs). Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed. Create training materials for EDC users and provide project-specific training as required. Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness. Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock). Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data. Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance. Organize and lead Quality Review activities during study. Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA). Manage the database maintenance, lock and close-out processes and procedure. Participate in conference calls and/or meetings with vendors and sponsors. Recognize and solve potential problems and evaluate effectiveness. Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date. Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned. Help to align data management and clinical programming best practices, standards and conventions within the company. Provide leadership, expertise and support to other department members. Propose and support initiatives for improving efficiency. Actively support to staff learning & development within the company. Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions. Represent the company at professional meetings, webinars or seminars. Train and mentor data managementstaff, support in development of new training material and provide training to relevant staff. Participate in the interview process for new recruits. Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes. Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients. Contribute to and take part in client evaluations and visits. Support in preparation of new proposals and budgets for Data Management services. Requirements To be successful you should possess: Life science, healthcare degree and/or combination of education and experience. Minimum 7 years of relevant work experience asa Clinical Data Manager. Minimum 7 years of experience in drug development and/or clinical research. Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements. Good understanding of Medical Terminology. Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA. Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock). Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation. Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models. Experience in developing data management standards. Strong written and verbal communication skills including a good command of the English language. Representative, outgoing and client-focused. Ability to work in a fast-paced challenging environment of a growing company. Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Administrative excellence. Attention to detail, strong technical, analytical and problem-solving skills. Strong project management skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations. Ability to simplify complex issues into understandable concepts. Excellent organizational, negotiating and motivational skills. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers : "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." Show more Show less

As an EDC IT Platform Engineer at AstraZeneca, you will join the R&D IT: EDC Product Team to provide support, manage, and maintain the EDC product, including various integration products. AstraZeneca's EDC System is Medidata's Rave, which is GxP compliant and a crucial part of Clinical Development Platforms used across late science teams in all therapeutic areas. Your key responsibilities will include facilitating discussions with stakeholders, providing SME technical support on system testing of the Core EDC Product and data integrations, performing impact analysis for system changes, conducting risk assessments during change implementations, following the validation lifecycle for upgrades and new integrations, and co-developing validation packages according to SOPs. Additionally, you will be involved in code review, solutioning for downstream customer requirements, participating in business meetings, handling day-to-day incidents and service requests, working towards incident reduction and automation, updating Service Now for events, creating GxP Validation Test cases in Jira Xray, executing validation tests, creating UAT test cases, and facilitating process requirements gathering. Mandatory skills for this role include extensive experience with Medidata RAVE UI, understanding of core configuration and clinical views, knowledge of data extraction capabilities, hands-on experience with Inbound Rave Web Services, SAS extracts, TSDV, and setting up Rave safety gateway and SAE notifications. You must also have expertise in system validation, strong communication and interpersonal skills, and adherence to ITIL guidelines. Preferred skills include hands-on experience with custom functions, SAS programming, Coder/Coder+ setup, outbound Rave Web Services, Rave backend data model, SQL script writing, and agile management tools. Knowledge of other programming languages, technical skills, and EDC testing experience is a plus. To qualify for this role, you should have a Bachelor's or Master's degree in computer science or a life science-related discipline with IT/CRO/Pharma experience and a total of 8+ years of experience. Join us at AstraZeneca to contribute to our innovative projects and grow your skills in a collaborative environment.,

Work Your Magic with us! Ready to explore, break barriers, and discover more We know youve got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich peoples lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That&aposs why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your Role Support the implementation and maintenance of data standards (including CRF, External Data, and SDTM) to ensure consistency across studies. Contribute to the creation of study-specific CRF (Case Report Form) metadata and SDTM (Study Data Tabulation Model) metadata Provide oversight for SDTM packages in outsourced studies, ensuring regulatory compliance, submission readiness, and adherence to standards (CDISC, FDA, EMA, etc.). Support eDC (electronic Data Capture) study set-up activities, including guidance to study teams for the build of non-standard CRF forms, and exemption management. Who You Are Minimum Requirements Bachelors degree in a relevant scientific or technical field, computer sciences, Data Management. 5-8 years of proven experience in the pharmaceutical or biotechnology industry. Proficiency with data management systems, with preference for experience in Rave Medidata. Good experience in eDC set-up activities, CRF build, and edit checks programming. Advanced knowledge of industry data standards and tools, including CDISC SDTM, CDASH, ODM-XML, and define.xml. Good understanding of regulatory requirements (FDA, EMA, CFDA, PMDA) and ICH-GCP guidelines. Strong analytical, problem-solving, and organizational skills. Strong attention to detail and accuracy in adhering to data standards and guidelines. Preferred Requirements Rave Medidata eDC build certified, SAS programming Proficiency in data standard governance principles and their application in the pharmaceutical industry. Demonstrated ability to support and lead data standardization initiatives within assigned projects or domains. Willingness to collaborate and learn from experienced team members to expand knowledge and expertise. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity! Show more Show less

JOB Description: Testing Engineer About Us: Inductive Quotient was founded by statisticians and technology industry experts with over 20 years of experience Inductive quotient aims to transform businesses and processes with its advanced digitization capabilities. With advanced AI and Machine Learning techniques we are helping Life Sciences industry to create a better healthcare system, and our Data Science capabilities helps organizations to create breakthrough solutions to transform businesses and drive sales growth. Website: www.inductivequotient.com We are seeking a skilled EDC Tester to validate the functionality, usability, compliance, and performance of our clinical EDC platform. You will be responsible for writing and executing test cases for study setup, subject visit flows, dynamic form logic (validations, derivations), and data integrity across various stages of the clinical trial lifecycle. Key Responsibilities Analyse EDC system specifications and design comprehensive test plans. Test core modules: Study Setup, Subject Management, Visit Schedules, Form Configuration, Dynamic Validations, Query Management, and SDV tracking. Perform UI, functional, regression, and integration testing. Log and track defects using tools like JIRA or TestRail. Collaborate with the QA lead, product managers, and developers to ensure test coverage. Mandatory Requirements Proven experience testing EDC systems (e.g., Medidata Rave, OpenClinica, Veeva Vault EDC, etc.) Strong understanding of clinical data workflows and study lifecycle Familiarity with CDISC/CDASH standards Experience testing form derivations, validations, skip logic , and audit trails Experience with API testing using Postman or similar tools Knowledge of 21 CFR Part 11 compliance and audit-ready systems. Good to Have Hands-on with automation testing frameworks Understanding of dynamic forms and clinical metadata models Background in clinical research or health informatics Experience : Experience (around 5years) Why Inductive Quotient? We are team a of 75+ talented and passionate professionals with strong statistical and analytical background combined with required study expertise. We IQians take lots of pride in our culture that enables open and creative thinking, deeply valuing our employees and their contributions towards our organization success.

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 Senior Clinical Data Manager I to join our A-team (hybrid*). The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, you will manage, coordinate, review, and approve DM deliverables from database design & set-up, through cleaning and reporting to database locking. It is crucial to ensure that the completeness, accuracy, and consistency of clinical data meet the quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. You will also be involved in Request for Proposals (RFPs) and present at Business Development (BD) Meetings. As a Senior Clinical Data Manager I, your key tasks will include: - Leading and serving as the primary contact for DM with all relevant parties internally and externally - Planning and projecting the resources required including management of tasks, timelines, risk, and quality - Developing, reviewing, and maintaining project-specific DM documents throughout the project lifecycle - Leading and coordinating the development of clinical study database set-up, eCRF design, and database validation requirements - Creating training materials for EDC users and providing project-specific training - Overseeing data cleaning strategy, data releases, data transfers, and reconciliation activities - Providing project metric reports, status updates, study progress, and feedback to the project team - Maintaining DM study documentation, supporting internal and external audits, and aligning data management and clinical programming best practices - Participating in client evaluations, preparing new proposals and budgets for Data Management services, and staying updated on regulatory development trends Requirements: - Life science, healthcare degree and/or combination of education and experience - Minimum 5 years of relevant work experience as a Clinical Data Manager - Thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and awareness of local/regional requirements - Experience with EDC software systems, IRT, eCOA, and CDISC conventions - Strong written and verbal communication skills, organizational, negotiating, and motivational skills - Ability to work in a fast-paced challenging environment and proficiency with computer applications Benefits of working at Allucent include: - Comprehensive benefits package - Competitive salaries - Departmental Study/Training Budget for professional development - Flexible working hours and remote/office-based working opportunities - Leadership and mentoring opportunities - Internal growth opportunities, employee referral program, and access to online training platforms *This position is for the Chennai Location and not home-based** *Please note that Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.*,

As a Data Standards Specialist at ICON plc, you will play a crucial role in supporting the standardization of data management practices. Your primary responsibility will involve creating and maintaining content in the Data Standards Catalog under guided supervision. You will collaborate with representatives from various functions, leveraging industry standards to develop clinical data collection instruments and associated checks. Your role will also involve updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. Participation in relevant governance team meetings and providing input on standards as assigned will be essential. Collaborating with Senior/Principal Data Standards Specialists or Managers to implement data standards strategy, ensuring compliance with regulations and internal governance procedures will be part of your responsibilities. As a subject matter expert (SME) for specific topics, you may provide ongoing support to the Data Management organization and key stakeholders such as Clinical, Biostatistics, Medical, and Medical Writing departments. Additionally, you will contribute to Data Management or cross-functional initiatives as needed and oversee CRO/FSP data managers and/or database development teams. You will represent the Data Standards team in various forums, including Data Standards Governance meetings, Clinical study team meetings, and Project update meetings. Demonstrating a foundational knowledge of Data Management and Data Standards processes, along with an awareness of industry best practices, is key to excelling in this role. Having a basic understanding of regulations like 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection is required. An ideal candidate would have a minimum of 2 years of clinical data standards experience in the biotechnology, pharmaceutical, or health-related industry. Possessing CDISC standards, SCDM certification, or Medidata RAVE certification is considered a plus. The role requires a Bachelor's degree in a Science, Health, Computing, or related field. At ICON, we value our employees and offer a competitive salary along with a range of benefits designed to promote well-being and work-life balance. Our benefits include various annual leave entitlements, health insurance options, retirement planning offerings, a Global Employee Assistance Programme, life assurance, and country-specific optional benefits like childcare vouchers, discounted gym memberships, and health assessments. To learn more about the benefits of working at ICON, visit our careers website at https://careers.iconplc.com/benefits. If you are interested in the role but unsure if you meet all the requirements, we encourage you to apply as you may be exactly what we are looking for at ICON, whether for this position or other roles.,

ICON plc is driving efficiencies through standardizing data management practices. As a Data Standards Specialist, you will play a crucial role in creating and maintaining content in the Data Standards Catalog. Working under guided supervision, you will collaborate with representatives from various functions to develop clinical data collection instruments and checks using industry standards. Your responsibilities will include updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. You will actively participate in governance team meetings, providing input on assigned standards. Collaborating with Senior/Principal Data Standards Specialists or Managers, you will help implement data standards strategy while ensuring compliance with regulations and internal governance procedures. In addition, you may serve as a subject matter expert (SME) for specific topics. You will offer ongoing support to the Data Management organization and key stakeholders such as Clinical, Biostatistics, Medical, and Medical Writing teams. Your role may also involve contributing to Data Management or cross-functional initiatives as required. Furthermore, you might oversee and hold accountable CRO/FSP data managers and/or database development teams. As part of the Data Standards team, you will represent ICON in various forums including Data Standards Governance meetings, clinical study team meetings, and project update meetings. To be successful in this role, you should demonstrate a foundational knowledge of Data Management and Data Standards processes, along with an understanding of industry best practices. A basic understanding of regulations such as 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards is required. Possession of CDISC standards, SCDM certification, or Medidata RAVE certification will be advantageous. A minimum of 2 years of clinical data standards experience in biotechnology, pharmaceutical, or health-related industry is necessary. Education-wise, a Bachelor's degree in a Science, Health, Computing, or related field is required. At ICON, we value our people and strive to build a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer a range of benefits tailored to promote well-being and work-life balance for you and your family. Our benefits include various annual leave entitlements, health insurance options, retirement planning offerings, a Global Employee Assistance Programme, life assurance, and country-specific optional benefits like childcare vouchers, gym memberships, and health assessments, among others. If you are interested in the role but unsure if you meet all requirements, we encourage you to apply as you may be exactly what we are looking for at ICON. Visit our careers website to learn more about the benefits of working with us: https://careers.iconplc.com/benefits For more information about reasonable accommodations, visit: https://careers.iconplc.com/reasonable-accommodations,

As a Senior Clinical Data Analyst, you will be responsible for creating Data Management Plans (DMP), eCasebook Guidelines (eCCGs), Edit Check Specifications, Data Review Listing Specifications, and other set-up documents. You will also perform User Acceptance Testing (UAT) and review the Electronic Data Capture (EDC) database to ensure data consistency and completeness. Your duties will include Listings Review, Query Management, managing Serious Adverse Events (SAE) and external vendor data reconciliation, analyzing data trends, and generating reports. Additionally, you will be involved in User Account Management, Study Metrics, Quality Control (QC), and EDC Archival. In the role of Senior Statistical Programmer, your responsibilities will include developing, validating, and maintaining programs and tools to generate reports and listings for data review. You will create data transfer specifications, train and mentor other programmers, and establish programming specifications. It will be vital to maintain all necessary programming documentation while adhering to quality and industry standards. You will act as a Subject Matter Expert (SME) for technical inquiries, monitor tasks that may fall within or outside the project scope, and develop, validate, deploy, and manage EDC study builds. Your expertise will be required in crafting tools and macros to enhance quality and efficiency, and your proficiency with industry data standards such as CDASH, SDTM, ADaM, etc., will be crucial. To qualify for this position, you should possess a minimum of 3 to 4 years of relevant experience in the field.,

We're looking for an experienced professional to join our team in Hyderabad, accountable for the setup and maintenance of External Data Streams within assigned clinical trials. You'll ensure these streams adhere to best practices and defined guidelines, contributing to the integrity and efficiency of our clinical data. Key Responsibilities Accountable for the setup and maintenance of External Data Streams within assigned trial(s) according to best practices and defined guidelines. External Data Streams include, but are not limited to, ePRO, eSource, EHR, Real World data , and traditional and novel clinical data streams (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS). Your activities and deliverables will include, but are not limited to: Development of trial-specific data transfer agreements and specifications . Verification of data transfers . Setup of automated data ingestion into the clinical data repository. Principal Relationships Reports to : A people manager position within the functional area (e.g., Data Acquisition Leader). Functional Contacts within IDAR (Internal) : Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations. Functional Contacts within JJ Innovative Medicine (as collaborator or peer) : Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources, and Project Coordinators. External Contacts : External partners and suppliers, CRO management and vendor liaisons, industry peers, and working groups. Education and Experience Requirements Required Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees (e.g., Master, PhD) are preferred. Approximately 5+ years of experience in the Pharmaceutical, CRO, or Biotech industry or a related field. Proven knowledge of data management practices (including tools and processes). Proven knowledge of regulatory guidelines (e.g., ICH-GCP) and standards (e.g., CDASH, SDTM). Intermediate project and risk management skills with an established track record of delivering successful outcomes. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors. Strong communication, leadership, influencing, and decision-making skills. Strong written and verbal communication skills (in English). Demonstrated technical expertise developing and maintaining External Data Streams (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS) and associated components (e.g., Data Transfer Agreements, Specifications, transfer file verification, data ingestion set-up). Preferred Innovative thinking for optimal design and execution of clinical development strategies. Ability to contribute to the development and implementation of business change or innovative ways of working. Experience working with data from EHR/EMR, Digital Health technologies, Real-World Data, or similar, eDC systems, eDC integration tools, and general data capture platforms .