Medidata RAVE Custom Functions experience REQUIRED * C# programming experience REQUIRED * Standards ... At least 8 years of clinical database developer experience in Rave with expertise in global library ...
Medidata RAVE Custom Functions experience REQUIRED * C# programming experience REQUIRED * Standards ... At least 8 years of clinical database developer experience in Rave with expertise in global library ...
Biotech Specialist - AI Trainer
Houston, TX · On-site +1
$1.1K - $1.4K/wk
Build a realistic digital workspace using tools like Medidata Rave , Oracle Clinical One , Schrödinger Suite , and Benchling . Include study protocols, IND/NDA/BLA drafts, and lab notebooks.
Quick apply
Biotech Specialist - AI Trainer
Houston, TX · On-site +1
$1.1K - $1.4K/wk
Build a realistic digital workspace using tools like Medidata Rave , Oracle Clinical One , Schrödinger Suite , and Benchling . Include study protocols, IND/NDA/BLA drafts, and lab notebooks.
Data Architect
Austin, TX · On-site
$100 - $130/hr
... Medidata Rave, Veeva, Oracle Clinical One, and custom sponsor environments. Your work directly ... You will partner with clinical operations, QC analysts, integration engineers, and AI/automation ...
Data Architect
Austin, TX · On-site
$100 - $130/hr
... Medidata Rave, Veeva, Oracle Clinical One, and custom sponsor environments. Your work directly ... You will partner with clinical operations, QC analysts, integration engineers, and AI/automation ...
Microsoft Office proficiency required - Outlook, Excel, Word Electronic Data Capture (EDC) System Experience required Medidata RAVE preferred Clinical Trial Management System Experience required ...
Microsoft Office proficiency required - Outlook, Excel, Word Electronic Data Capture (EDC) System Experience required Medidata RAVE preferred Clinical Trial Management System Experience required ...
Clinical Data Manager
Austin, TX · On-site
$125K - $175K/yr
Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva, Oracle InForm) * Strong understanding of clinical data standards (CDISC, SDTM) * Experience managing CROs and external vendors
Clinical Data Manager
Austin, TX · On-site
$125K - $175K/yr
Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva, Oracle InForm) * Strong understanding of clinical data standards (CDISC, SDTM) * Experience managing CROs and external vendors
Clinical Data Manager
Austin, TX · Remote
$125K - $175K/yr
Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva, Oracle InForm) * Strong understanding of clinical data standards (CDISC, SDTM) * Experience managing CROs and external vendors
Clinical Data Manager
Austin, TX · Remote
$125K - $175K/yr
Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva, Oracle InForm) * Strong understanding of clinical data standards (CDISC, SDTM) * Experience managing CROs and external vendors
Senior Data Team Lead (Remote)
Dallas, TX · Remote
$86K - $217K/yr
Expertise with Medidata Rave, Oracle InForm, or similar EDC systems. * Strong understanding of GCP, ICH, and clinical research processes. * Excellent communication and leadership skills. * An ...
Senior Data Team Lead (Remote)
Dallas, TX · Remote
$86K - $217K/yr
Expertise with Medidata Rave, Oracle InForm, or similar EDC systems. * Strong understanding of GCP, ICH, and clinical research processes. * Excellent communication and leadership skills. * An ...
Senior Data Team Lead (Remote)
Austin, TX · Remote
$86K - $217K/yr
Expertise with Medidata Rave, Oracle InForm, or similar EDC systems. * Strong understanding of GCP, ICH, and clinical research processes. * Excellent communication and leadership skills. * An ...
Senior Data Team Lead (Remote)
Austin, TX · Remote
$86K - $217K/yr
Expertise with Medidata Rave, Oracle InForm, or similar EDC systems. * Strong understanding of GCP, ICH, and clinical research processes. * Excellent communication and leadership skills. * An ...
Site Manager
Houston, TX · On-site
Ensures timely responses to clinical site staff and all regulatory agencies * Develop strong ... Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc ...
Site Manager
Houston, TX · On-site
Ensures timely responses to clinical site staff and all regulatory agencies * Develop strong ... Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc ...
Site Manager
Houston, TX · On-site
Ensures timely responses to clinical site staff and all regulatory agencies * Develop strong ... Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc ...
Site Manager
Houston, TX · On-site
Ensures timely responses to clinical site staff and all regulatory agencies * Develop strong ... Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc ...
Venture Builder | HealthCare + Robotics
Houston, TX · On-site
$80K - $94K/yr
... freelance). Our preferred location is New York, but we will be open to considering hybrid ... Demonstrated 0→1 experience in healthcare robotics, robotics-as-a-service, clinical operating ...
Quick apply
Venture Builder | HealthCare + Robotics
Houston, TX · On-site
$80K - $94K/yr
... freelance). Our preferred location is New York, but we will be open to considering hybrid ... Demonstrated 0→1 experience in healthcare robotics, robotics-as-a-service, clinical operating ...
Venture Builder | HealthCare + Robotics
Austin, TX · On-site
$80K - $94K/yr
... freelance). Our preferred location is New York, but we will be open to considering hybrid ... Demonstrated 0→1 experience in healthcare robotics, robotics-as-a-service, clinical operating ...
Quick apply
Venture Builder | HealthCare + Robotics
Austin, TX · On-site
$80K - $94K/yr
... freelance). Our preferred location is New York, but we will be open to considering hybrid ... Demonstrated 0→1 experience in healthcare robotics, robotics-as-a-service, clinical operating ...
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Full-time
This job post has expired 1 day ago. Applications are no longer accepted.
IQVIA rating
8.1
Based on 53 frontline employees who took The Breakroom Quiz
61st of 223 rated it services
Job description
- Participate in the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF (e.g., lab, Imaging, or ECG)) data mappings.
- To develop operational mappings, utilize Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), controlled terminology, and other applicable industry standards.
- SME on operational data standards utilizing SDTM standards and CDISC controlled terminology in developing operational data standards.
- Contributing to developing and applying smart systems and optimal approaches to support data collection.
- Independently identify and propose process improvements while maintaining a strategic focus. Share new industry standards and best practices with project and study teams and departments as required.
- Participate and/or lead in developing Global Clinical Data Standards and other cross-functional SOPs, Working Procedures, Guidance documents, and job aids.
- Participate and/or lead in identifying, reviewing, evaluating, and implementing new data standards-related technologies.
- Managing work assignments to ensure timely delivery of global library objects.
- Identify and resolve issues that may negatively impact the delivery of global library objects and escalate to leadership as needed.
- Medidata Rave global library standard objects (e.g., eCRF forms, edit checks).
- Build, maintain, and document the Medidata Rave global library standard objects (e.g., eCRF forms, edit checks) to facilitate the creation of study-level databases.
- Work with Data Managers and EDC Programmers to implement new or modified global library objects (e.g., ensure DM and EDCP clearly understand global library objects).
- Build and maintain CRF Completion Guidelines for all standard forms.
- Support and participate in the Standards Core Committee (SCC).
- Partner with functional area stewards.
- Organize standards topics to be reviewed and ensure decisions are made on time.
- Document meeting minutes and other discussions.
- Provide input and information to facilitate critical discussions and decisions regarding standards use and implementation.
- Support preparation of materials for the Standards Governance Committee (SGC) and address all comments received until all objects in scope get approved.
- Follow procedural documents and participate in reviewing and updating documents to ensure they reflect industry standards and are easily followed.
- Communicate and reinforce content and interpretation of Kite data standards to project and study teams to ensure consistency in understanding and implementing standards across a project.
- Participate in relevant study and project team meetings as standards SME and provide input for standards components, such as CRF design, CRF Completion Guidelines, programmed edit checks, Data transfer specifications, mapping specifications, and annotated CRF.
- Liaising with and reviewing work delivered by external partners (e.g., Function Service Providers, CROs, technology providers, etc.).
- Developing strong and productive working relationships with key stakeholders throughout CDMs, Clinical Ops, and Kite with the ability to think strategically across a broad portfolio and effectively express their views to senior management.
- Participate and/or lead in strategic initiatives, special projects, and working groups contributing to business decisions and process changes.
- Develop training materials and provide training on CDSM and GLIB-developed processes.
- Provide mentoring, coaching, and escalation support to more junior personnel or contract staff, as required.
- Representing the Company in interactions with key external partners as part of any committee or industry group.
Required Experience
Medidata RAVE experience REQUIRED
Medidata RAVE Custom Functions experience REQUIRED
C# programming experience REQUIRED
Standards Governance experience (CDISC) REQUIRED
Candidates whose resumes do not clearly demonstrate Medidata RAVE, Custom Functions, C#, and Standards Governance experience will not be progressed for review. These are mandatory requirements for consideration.
- Meditdata MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Data Standards OR
- BS/BA in life science or related discipline and 6+ years of experience in Clinical Data Standards OR
- High School degree and 10+ years of experience in Clinical Data Standards.
- MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Data Standards OR
- At least 6 years of relevant industry experience with clinical trials and a successful track record of leading through influence, working across complex, global organizational matrices.
- Experience in Industry Standards (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models.
- At least 8 years of clinical database developer experience in Rave with expertise in global library development and development of standard data collection objects.
- Strong understanding of the drug development process with proven expertise in clinical trial execution and global library development/clinical database development in a global arena.
- Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva, Medrio, Oracle, TrialGrid, etc.) and well-versed in industry trends and emerging technologies supporting data collection.
- Understanding database and dictionary structures (e.g., MedDRA, WHODrug).
- Experience interpreting Health Authority regulations and GCP/ICH guidelines with a strong compliance background.
- Strong working knowledge of the overall pharmaceutical development process.
- Strong working knowledge of SDTM and creating data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml.
- Experience in CRF design, query resolution, and general data validation.
- Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
- Excellent verbal and written communication skills, high ability to communicate standards-related issues, options, and their impact to project teams and within the department.
- Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality, etc.).
- Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $84,600.00 - $211,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.About IQVIA
Sourced by ZipRecruiter
At IQVIA, we are passionate about helping customers and partners improve results and patient outcomes. Everything we do contributes to this vision for creating a healthier world. In today’s healthcare environment, it’s not only about how much data, information, and technology you have at your fingertips – it’s what you do with it. IQVIA is focused on making intelligent connections for customers across the entire healthcare ecosystem to help you drive healthcare forward. Whether that means partnering with novel technology companies to boost patient engagement, leveraging AI & machine learning to accelerate results, or using decentralized trials to reach the right patients wherever they are – we are always looking for smarter ways to move you forward.
Industry
Health care and social assistance
Company size
10,000+ Employees
Headquarters location
Durham, NC, US