Data Standards Manager III
2 days ago
- Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides as well as FDA guidance and regulation regarding electronic submission of data.
- Keeps abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing.
- eCRF Design - Demonstrates extensive understanding of CDASH and SDTM standards and concepts.
- ble to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards.
- Recognizes limitations if eCRF design and correct flaws proactively.
- SDTM Conformance Mapping - Demonstrate extensive understanding of SDTM, Standard Terminology and common coding dictionaries.
- Reviews SDTM conformance mapping specifications and corrects flaws proactively.
- CDISC Validation Tools - Demonstrates knowledge of rules for SDTM and the associated define.xml file or rules for ADaM and the associated define.xml file and able to appropriately interpret results from common validation tools.
- Executes validation tools and collaborates with other functions to resolve identified issues.
- Ensure any unresolved issues are appropriately documented (for example in the FDA's Data Reviewer's Guides).
- Metadata Repository - Responsible for managing libraries of CDISC-related metadata, terminology and related standards within the metadata repository.
- Provides governance oversight to Data Standards Analyst and Sr Data Standards Analyst to ensure consistency in metadata.
- Policies & Procedures - Assist in the development of data standards policies, procedures and practices.
- Communication - Clearly communicates an understanding of clinical data standards concepts, clinical principles, and regulatory guidance and acts in accordance with those principles.
- Effectively presents data standards concepts and logical arguments to statistical programmers, statisticians, data scientists, clinical development and regulatory.
- ble to diplomatically and persuasively represent the interests of the Data Standards group in cross-functional initiatives.
- Training & Mentoring - Effectively mentoring peers on the Data Standards team regarding data standards and functional operations.
- Train new Data Standards Analysts on process and systems related to the management and implementation of data standards.
- CDISC involvement - Maintains external reputation of a clinical data standards expert.
- Ensures consolidated review comments from Data Standards group and Statistical Programming are provided for applicable CDISC standards released for public review.
- Submits at least one abstract per year for presentation at a CDISC Interchange.
- Expert level of knowledge of at least three areas of clinical data standards, and high level of knowledge in at least one additional area.
- reas include CDASH, SDTM, ADaM, define.xml and controlled terminology. SDTM expertise is required.
- Familiarity with other clinical data standards including BRIDG, ODM and SHARE.
- Experience in mapping and converting legacy data into SDTM domains for eCTD submissions.
- Minimum of two successful submissions of CDISC compliant data.
- Knowledge of international regulations, requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.
- Experience with metadata repository technology and its application in clinical data standards processes and experience with data standards governance.
- Experience in supporting the development of standard procedures, guidelines and templates.
-
Clinical Application Specialist III
1 week ago
Lake Bluff, IL, United States Katalyst Healthcares and Life Sciences Full timeJob description: Describe the primary goals, objectives or functions or outputs of this position. This role is responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data sets for one or more compounds/indications or therapeutic areas. This role must effectively interface with team...
-
HR Data Specialist
2 days ago
Lake Bluff, IL, United States Orion Group Full timeHR Data Specialist Contract: 6-Month Initial Term (possible extension) Schedule: Hybrid | 3 Days Onsite (Tuesday-Thursday) / 2 Days Remote Location: North Chicago, IL Pay Rate: $30/hour Orion Group is seeking a detail-oriented HR Data Specialist to join our client's HR Operations Department, a shared services environment supporting global HR and payroll...
-
HR Data Specialist
20 hours ago
Lake Bluff, IL, United States Orion Group Full timeHR Data Specialist Contract: 6-Month Initial Term (possible extension) Schedule: Hybrid | 3 Days Onsite (Tuesday-Thursday) / 2 Days Remote Location: North Chicago, IL Pay Rate: $30/hour Orion Group is seeking a detail-oriented HR Data Specialist to join our client's HR Operations Department, a shared services environment supporting global HR and payroll...
-
Data Scientist II
2 days ago
Lake Bluff, IL, United States Katalyst Healthcares and Life Sciences Full timeJob Description: s a Real-World Data (RWD) Scientist, you will be part of a team powering data driven insights that lead to better, faster decisions and therapies for our patients. Acting as a lead data scientist in your project area, you will contribute RWD expertise to broader cross-functional initiatives. Candidates should be excited to drive...
-
Data Scientist II
1 week ago
Lake Bluff, IL, United States Katalyst Healthcares and Life Sciences Full timeJob Description: s a Real-World Data (RWD) Scientist, you will be part of a team powering data driven insights that lead to better, faster decisions and therapies for our patients. Acting as a lead data scientist in your project area, you will contribute RWD expertise to broader cross-functional initiatives. Candidates should be excited to drive...
-
Medical Reviewer/Safety Reviewer III
7 days ago
Lake Bluff, IL, United States Katalyst Healthcares and Life Sciences Full timeJob Description: The Med Reviewer has a key role within the designated Therapeutic Area. Working under the leadership of the Scientific Director/Medical Director, this leader supports the development and execution of the therapeutic area medical strategy, specifically as it pertains to the specific asset or indication by providing scientific, strategic and...
-
Maintenance Technician III
2 hours ago
Lake Zurich, IL, United States HelloFresh Full timeMaintenance Technician III As a Maintenance Technician III, you will work with the maintenance team to maintain and repair conveyance, automation and facilities equipment to support operations uptime and improve reliability of our systems. Shift: Sunday to Wednesday - 3:00pm to 1:30am. You will: Maintain compliance with all safety, food safety, and security...
-
Maintenance Technician III
26 minutes ago
Lake Zurich, IL, United States HelloFresh Full timeMaintenance Technician III As a Maintenance Technician III, you will work with the maintenance team to maintain and repair conveyance, automation and facilities equipment to support operations uptime and improve reliability of our systems. Shift: Sunday to Wednesday - 3:00pm to 1:30am. You will: Maintain compliance with all safety, food safety, and security...
-
Maintenance Technician III
28 minutes ago
Lake Zurich, IL, United States HelloFresh Full timeMaintenance Technician III As a Maintenance Technician III, you will work with the maintenance team to maintain and repair conveyance, automation and facilities equipment to support operations uptime and improve reliability of our systems. Shift: Sunday to Wednesday - 3:00pm to 1:30am. You will: Maintain compliance with all safety, food safety, and security...
-
Clinical Project Manager I
2 weeks ago
Lake Bluff, IL, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Support Digital Strategy Lead in the development of digital strategy and Client endpoint and provide input in the patient insight research, technologies evaluation, usability testing, vendor qualification, and validation of digital health tools for use in clinical trials. Collaborate with medical colleagues and Therapeutic Areas to...
