4,420 Clinical Standards jobs in the United States
ASSOCIATE DIRECTOR OF CLINICAL STANDARDS
Posted 1 day ago
Job Viewed
Job Description
Position Purpose The Associate Director of Clinical Standards ensures compliance with ethical, legal, and documentation requirements across CFR. This role leads quality assurance initiatives, serves as the HIPAA Compliance Officer, and works collaboratively to maintain CFR's clinical policies and training materials. The position supports clinician education on clinical standards, helps CFR remain a leader in accessible, ethical, and high-quality therapy. Key Functions and Responsibilities Compliance, Ethics, & Risk Management Serve as CFR's HIPAA Compliance Officer; ensure adherence to privacy and confidentiality protocols. Monitor compliance with CFR policies, state and federal regulations, and the AAMFT Code of Ethics. Support CFR's risk management infrastructure and respond to documentation or privacy concerns. Quality Assurance & Documentation Systems Develop and implement systems for client chart audits, clinical documentation review, and internal quality controls. Reports to the Director of Clinical Operations and align documentation standards with workflow systems. Lead regular reviews and updates to CFR's Clinical Manual and consent forms. Clinician Support & Training Educate new and existing clinicians on documentation practices, compliance policies, and ethical standards. Provide consultation on complex clinical, legal, or ethical cases. Participate in onboarding to reinforce compliance expectations and documentation norms. Policy & Special Projects Prepare or review documents for new education, clinical, or group therapy initiatives. Contribute to CFR-wide training sessions, peer review meetings, and internal evaluations. Collaborate with the Clinical Leadership Team on strategic initiatives related to clinical excellence. Clinical Contribution Maintain a part-time caseload (minimum 8 clients/week or 34/month) subject to the clinical job description and compensation plan. (SEE BELOW) Serve as a model for best practices in documentation, cultural humility, and quality clinical care. Required Qualifications Advanced degree in Marriage and Family Therapy or related mental health field. Licensure in relevant discipline (LMFT, LCSW, LPC, etc.) preferred. 7+ years of clinical experience with strong compliance/ethics background. Qualities Sought Excellent attention to detail and high accountability. Ability to apply ethical reasoning in complex clinical situations. Collaborative spirit and commitment to CFR's values. Working Conditions and Environment This position is hybrid, with a combination of remote work and in-person meetings at CFR office locations as needed. Physical Requirements The position requires repetitive motion, such as standing, walking, sitting and bending. Light lifting, up to 20 pounds, may be required. CLINICAL REQUIREMENT SUBJECT TO THE PART-TIME THERAPIST JOB DESCRIPTION: Part-time therapists at Council for Relationships are W-2, fee-for-service employees. They are highly skilled clinicians who provide exceptional clinical care, complete all documentation and administrative duties, and engage in their own caseload-building and marketing. They are expected to maintain a minimum caseload of 8 clients but are welcome to see more than that. The position is flexible, and therapists are able to set their own schedules and rates. Therapists report to their Office Director and the Director of Clinical Operations. RESPONSIBILITIES: Conduct high-quality therapy in a manner that is ethical, in conformity with established professional standards, in compliance with HIPAA regulations, and accountable and accessible to peer review. Follow Council clinical policies, procedures, and protocols. Utilize Council's practice management software system. Maintain the highest standards of professional practice, including completing client case files in a timely manner and respecting client confidentiality. Attend group clinical supervision. Attend monthly all staff meetings as schedule allows. Attend monthly clinical specialty group meetings as schedule allows. Meet monthly clinical productivity requirements. Maintain an updated profile on the Council website. Submit writing for Council internal and external communications/marketing pieces. COMPENSATION: Therapists are paid a variable percentage (50%-65%) of the fees they charge. #J-18808-Ljbffr
Senior Manager, Clinical Data Standards
Posted today
Job Viewed
Job Description
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 wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Senior Manager, Clinical Data Standards, Bristol-Myers Squibb Company** **,** **Princeton, NJ** **.** Develop, maintain and implement clinical data standards. Participate in the development and maintenance of global clinical data standards, including operational CDISC SDTM, controlled terminology, non-CRF standard data mappings (lab or ECG) and other applicable industry standards. Create metadata and mappings between the standards (operational and SDTM), and documentation of the use of the standard. Provide input for standards components, such as CRF design, CRF completion guidelines, programmed edit checks, data transfer specifications, SDTM mapping specifications and SDTM annotated CRF. Act as an expert on operational data standards, SDTM and/or Analysis Data Model (ADaM) standards and CDISC controlled terminology. Validate SDTM domains, which may include output from industry standard software tools and BMS custom validation programs. Work with standards management systems and software, such as MDR, Change Request Systems, SDTM validation systems and issues tracking systems. Communicate and reinforce content and interpretation of BMS data standards to project and study teams to ensure consistency in understanding and implementation of standards across a project. Process clinical data change requests for new or existing metadata, including developing a standards manager recommendation and implementation plan for the standard, as applicable, and ensure that the request is processed through the appropriate levels of the Central Drugs Standard Control Organization (CDSCO). Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements (SDTM annotated CRF, define.xml/pdf, Reviewer's Guide and XPT files). Participate in the identification, review, evaluation and implementation of new technologies related to data standards.
40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. $174,400 - 235,280/yr.
**MINIMUM REQUIREMENTS** :
Master's degree or foreign equivalent degree in Microbiology, Clinical Research, or a related life science field, and eight (8) years of post-baccalaureate experience.
In the alternative, the employer will accept a bachelor's degree or foreign equivalent degree in Microbiology, Clinical Research, or a related life science field, and ten (10) years of post-baccalaureate experience.
Must have experience with/in:
+ Clinical Trial Data,
+ Pharmaceutical development process,
+ Health Authority regulations,
+ Good Clinical Trial (GCT) practice,
+ Regulatory requirements,
+ Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (CDISC SDTM), Collection (CDASH), Tabulation (SDTM) or analysis (ADaM) models,
+ Define.xml,
+ Medidata Rave electronic Data Capture (EDC),
+ data mapping specifications,
+ annotated CRFs,
+ CRF design,
+ data validation,
+ Metadata
+ Repository (MDR) and
+ SAS.
The required skills do not need to be maintained over the full term of required experience.
May work remotely within normal commuting distance of Princeton, NJ.
To apply, email resume and reference R1592891 in the subject line of the email to .
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
*** If BMS Careers Site link is not copying and pasting correctly, please add manually using the following address: .
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1592891
**Updated:** 2025-07-31 01:10:18.145 UTC
**Location:** Princeton LVL-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Director, Clinical Data and Reporting Standards
Posted 3 days ago
Job Viewed
Job Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Purpose
The Director of Clinical Standards is a leadership role which sets the strategy for development and governance of clinical data and reporting standards. This role carries significant autonomy in envisioning and deploying modern technology and AI powered standards development and is directly responsible for ensuring that AbbVie's clinical data collection conforms to CDISC standards and all applicable regulatory requirements ensuring submission ready SDTM data . He/She is responsible for fostering standards-based culture through stakeholder collaborations, establishing training programs and promoting adoption of best practices.
Responsibilities
+ Industry Standards - Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulations 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. Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations of eCRF design and suggests solutions proactively.
+ SDTM Conformance Mapping - Demonstrates extensive understanding of SDTM, Standard Terminology and common coding dictionaries. Able to critically review SDTM conformance mapping specifications.
+ CDISC Validation Tools - Demonstrates extensive knowledge of SDTM, ADaM and define.xml validation rules and able to appropriately interpret results from common validation tools.
+ Technology - Responsible for configuration of the Metadata Repository and maintaining optimum business process for managing libraries of CDISC related metadata, terminology and related standards.
+ Programming Standards - Has technical acumen to effectively collaborate with Statistical Programmers in co-leading development of programming standards maintained within the Statistical Computing Environment.
+ Policies and Procedures - Develop, implement and execute data standards policies, procedures, and practices.
+ Communication - Effectively and persuasively presents data standards concepts, assessment of risks and logical arguments to R&D functions, especially statistical programmers, statisticians, data scientists, data managers, medical directors, and regulatory function.
+ Training and Mentoring - Provides strong professional and technical leadership to maintain highly motivated staff. Arranges appropriate training opportunities for staff to facilitate their timely career development. Ensures consistency of training opportunities across the organization. Ensures that self and staff are compliant with training requirements.
+ Resource Management - Manages data standards staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality. Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects.
+ Performance Management - Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views.
Qualifications
+ MS with 12+ or BS with 14+ years of relevant clinical development experience.
+ Expert level of knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define and controlled terminology.
+ Experience in mapping and converting legacy data into SDTM domains for eCTD submissions. Minimum of two successful submissions of CDISC compliant data.
+ Experience in developing/instituting standard procedures, guidelines and templates.
+ Knowledge of international regulations, requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.
+ Technical skills and experience in directly managing and/or collaborating with the programming group on end-to-end standardization and automation
+ Experience with metadata repository technology and its application in clinical data standards
*This position will be required to sit on-site 3 days / week in Lake County
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ?
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees?
+ This job is eligible to participate in our short-term incentive programs. ?
+ This job is eligible to participate in our long-term incentive programs?
?
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. ?
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Director, Clinical Data and Reporting Standards
Posted 3 days ago
Job Viewed
Job Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Purpose
The Director of Clinical Standards is a leadership role which sets the strategy for development and governance of clinical data and reporting standards. This role carries significant autonomy in envisioning and deploying modern technology and AI powered standards development and is directly responsible for ensuring that AbbVie's clinical data collection conforms to CDISC standards and all applicable regulatory requirements ensuring submission ready SDTM data . He/She is responsible for fostering standards-based culture through stakeholder collaborations, establishing training programs and promoting adoption of best practices.
Responsibilities
+ Industry Standards - Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulations 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. Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations of eCRF design and suggests solutions proactively.
+ SDTM Conformance Mapping - Demonstrates extensive understanding of SDTM, Standard Terminology and common coding dictionaries. Able to critically review SDTM conformance mapping specifications.
+ CDISC Validation Tools - Demonstrates extensive knowledge of SDTM, ADaM and define.xml validation rules and able to appropriately interpret results from common validation tools.
+ Technology - Responsible for configuration of the Metadata Repository and maintaining optimum business process for managing libraries of CDISC related metadata, terminology and related standards.
+ Programming Standards - Has technical acumen to effectively collaborate with Statistical Programmers in co-leading development of programming standards maintained within the Statistical Computing Environment.
+ Policies and Procedures - Develop, implement and execute data standards policies, procedures, and practices.
+ Communication - Effectively and persuasively presents data standards concepts, assessment of risks and logical arguments to R&D functions, especially statistical programmers, statisticians, data scientists, data managers, medical directors, and regulatory function.
+ Training and Mentoring - Provides strong professional and technical leadership to maintain highly motivated staff. Arranges appropriate training opportunities for staff to facilitate their timely career development. Ensures consistency of training opportunities across the organization. Ensures that self and staff are compliant with training requirements.
+ Resource Management - Manages data standards staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality. Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects.
+ Performance Management - Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views.
Qualifications
+ MS with 12+ or BS with 14+ years of relevant clinical development experience.
+ Expert level of knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define and controlled terminology.
+ Experience in mapping and converting legacy data into SDTM domains for eCTD submissions. Minimum of two successful submissions of CDISC compliant data.
+ Experience in developing/instituting standard procedures, guidelines and templates.
+ Knowledge of international regulations, requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.
+ Technical skills and experience in directly managing and/or collaborating with the programming group on end-to-end standardization and automation
+ Experience with metadata repository technology and its application in clinical data standards
*This position will be required to sit on-site 3 days / week in Irvine
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ?
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees?
+ This job is eligible to participate in our short-term incentive programs. ?
+ This job is eligible to participate in our long-term incentive programs?
?
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. ?
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Director, Clinical Data and Reporting Standards
Posted 3 days ago
Job Viewed
Job Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Purpose
The Director of Clinical Standards is a leadership role which sets the strategy for development and governance of clinical data and reporting standards. This role carries significant autonomy in envisioning and deploying modern technology and AI powered standards development and is directly responsible for ensuring that AbbVie's clinical data collection conforms to CDISC standards and all applicable regulatory requirements ensuring submission ready SDTM data . He/She is responsible for fostering standards-based culture through stakeholder collaborations, establishing training programs and promoting adoption of best practices.
Responsibilities
+ Industry Standards - Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulations 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. Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations of eCRF design and suggests solutions proactively.
+ SDTM Conformance Mapping - Demonstrates extensive understanding of SDTM, Standard Terminology and common coding dictionaries. Able to critically review SDTM conformance mapping specifications.
+ CDISC Validation Tools - Demonstrates extensive knowledge of SDTM, ADaM and define.xml validation rules and able to appropriately interpret results from common validation tools.
+ Technology - Responsible for configuration of the Metadata Repository and maintaining optimum business process for managing libraries of CDISC related metadata, terminology and related standards.
+ Programming Standards - Has technical acumen to effectively collaborate with Statistical Programmers in co-leading development of programming standards maintained within the Statistical Computing Environment.
+ Policies and Procedures - Develop, implement and execute data standards policies, procedures, and practices.
+ Communication - Effectively and persuasively presents data standards concepts, assessment of risks and logical arguments to R&D functions, especially statistical programmers, statisticians, data scientists, data managers, medical directors, and regulatory function.
+ Training and Mentoring - Provides strong professional and technical leadership to maintain highly motivated staff. Arranges appropriate training opportunities for staff to facilitate their timely career development. Ensures consistency of training opportunities across the organization. Ensures that self and staff are compliant with training requirements.
+ Resource Management - Manages data standards staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality. Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects.
+ Performance Management - Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views.
Qualifications
+ MS with 12+ or BS with 14+ years of relevant clinical development experience.
+ Expert level of knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define and controlled terminology.
+ Experience in mapping and converting legacy data into SDTM domains for eCTD submissions. Minimum of two successful submissions of CDISC compliant data.
+ Experience in developing/instituting standard procedures, guidelines and templates.
+ Knowledge of international regulations, requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.
+ Technical skills and experience in directly managing and/or collaborating with the programming group on end-to-end standardization and automation
+ Experience with metadata repository technology and its application in clinical data standards
*This position will be required to sit on-site 3 days / week in South San Francisco
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ?
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees?
+ This job is eligible to participate in our short-term incentive programs. ?
+ This job is eligible to participate in our long-term incentive programs?
?
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. ?
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Director, Clinical Data and Reporting Standards
Posted 7 days ago
Job Viewed
Job Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Purpose
The Director of Clinical Standards is a leadership role which sets the strategy for development and governance of clinical data and reporting standards. This role carries significant autonomy in envisioning and deploying modern technology and AI powered standards development and is directly responsible for ensuring that AbbVie's clinical data collection conforms to CDISC standards and all applicable regulatory requirements ensuring submission ready SDTM data . He/She is responsible for fostering standards-based culture through stakeholder collaborations, establishing training programs and promoting adoption of best practices.
Responsibilities
+ Industry Standards - Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulations 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. Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations of eCRF design and suggests solutions proactively.
+ SDTM Conformance Mapping - Demonstrates extensive understanding of SDTM, Standard Terminology and common coding dictionaries. Able to critically review SDTM conformance mapping specifications.
+ CDISC Validation Tools - Demonstrates extensive knowledge of SDTM, ADaM and define.xml validation rules and able to appropriately interpret results from common validation tools.
+ Technology - Responsible for configuration of the Metadata Repository and maintaining optimum business process for managing libraries of CDISC related metadata, terminology and related standards.
+ Programming Standards - Has technical acumen to effectively collaborate with Statistical Programmers in co-leading development of programming standards maintained within the Statistical Computing Environment.
+ Policies and Procedures - Develop, implement and execute data standards policies, procedures, and practices.
+ Communication - Effectively and persuasively presents data standards concepts, assessment of risks and logical arguments to R&D functions, especially statistical programmers, statisticians, data scientists, data managers, medical directors, and regulatory function.
+ Training and Mentoring - Provides strong professional and technical leadership to maintain highly motivated staff. Arranges appropriate training opportunities for staff to facilitate their timely career development. Ensures consistency of training opportunities across the organization. Ensures that self and staff are compliant with training requirements.
+ Resource Management - Manages data standards staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality. Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects.
+ Performance Management - Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views.
Qualifications
+ MS with 12+ or BS with 14+ years of relevant clinical development experience.
+ Expert level of knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define and controlled terminology.
+ Experience in mapping and converting legacy data into SDTM domains for eCTD submissions. Minimum of two successful submissions of CDISC compliant data.
+ Experience in developing/instituting standard procedures, guidelines and templates.
+ Knowledge of international regulations, requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.
+ Technical skills and experience in directly managing and/or collaborating with the programming group on end-to-end standardization and automation
+ Experience with metadata repository technology and its application in clinical data standards
*This position will be required to sit on-site 3 days / week in New Jersey
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ?
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees?
+ This job is eligible to participate in our short-term incentive programs. ?
+ This job is eligible to participate in our long-term incentive programs?
?
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. ?
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Director, Clinical Data and Reporting Standards
Posted today
Job Viewed
Job Description
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job DescriptionPurpose
The Director of Clinical Standards is a leadership role which sets the strategy for development and governance of clinical data and reporting standards. This role carries significant autonomy in envisioning and deploying modern technology and AI powered standards development and is directly responsible for ensuring that AbbVie’s clinical data collection conforms to CDISC standards and all applicable regulatory requirements ensuring submission ready SDTM data . He/She is responsible for fostering standards-based culture through stakeholder collaborations, establishing training programs and promoting adoption of best practices.
Responsibilities
- Industry Standards - Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulations 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. Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations of eCRF design and suggests solutions proactively.
- SDTM Conformance Mapping - Demonstrates extensive understanding of SDTM, Standard Terminology and common coding dictionaries. Able to critically review SDTM conformance mapping specifications.
- CDISC Validation Tools - Demonstrates extensive knowledge of SDTM, ADaM and define.xml validation rules and able to appropriately interpret results from common validation tools.
- Technology - Responsible for configuration of the Metadata Repository and maintaining optimum business process for managing libraries of CDISC related metadata, terminology and related standards.
- Programming Standards - Has technical acumen to effectively collaborate with Statistical Programmers in co-leading development of programming standards maintained within the Statistical Computing Environment.
- Policies and Procedures - Develop, implement and execute data standards policies, procedures, and practices.
- Communication - Effectively and persuasively presents data standards concepts, assessment of risks and logical arguments to R&D functions, especially statistical programmers, statisticians, data scientists, data managers, medical directors, and regulatory function.
- Training and Mentoring - Provides strong professional and technical leadership to maintain highly motivated staff. Arranges appropriate training opportunities for staff to facilitate their timely career development. Ensures consistency of training opportunities across the organization. Ensures that self and staff are compliant with training requirements.
- Resource Management - Manages data standards staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality. Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects.
- Performance Management - Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views.
- MS with 12+ or BS with 14+ years of relevant clinical development experience.
- Expert level of knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define and controlled terminology.
- Experience in mapping and converting legacy data into SDTM domains for eCTD submissions. Minimum of two successful submissions of CDISC compliant data.
- Experience in developing/instituting standard procedures, guidelines and templates.
- Knowledge of international regulations, requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.
- Technical skills and experience in directly managing and/or collaborating with the programming group on end-to-end standardization and automation
- Experience with metadata repository technology and its application in clinical data standards
*This position will be required to sit on-site 3 days / week in Lake County
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit -us/equal-employment-opportunity-employer.html
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Quality Assurance Quality Assurance T
Posted 1 day ago
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Job Description
Quality Assurance Technician
Job ID:
39349
Location:
Youngstown, OH, US
High-School Diploma
Location Type:
On-site
Talent Area:
Quality
Job Summary:
Quality Assurance Technicians are responsible for identifying and communicating any defects on product. This position involves conducting various sampling and measuring tests in order to ensure the product is meeting customer specifications and is consistent. This position shall communicate with the Production Manager, operators on all lines.
Job Duties:
Conduct product sampling and testing to ensure cans are within customer specifications and consistent production is being met.
Perform product sampling and testing such as metal exposure testing, coating adhesion and abrasion resistance, burst and buckle performance and overflow capacity and particulate identification and measurement.
Inspect barcodes, text and graphics.
Sample and select product for retain storage.
File proper paperwork such as start-up sheets.
Input product and process data.
Collect pre-delivery samples (PDS).
Perform finished goods inspection.
Authority to stop and/or modify work processes due to non-conformance and/or unsafe working conditions.
Report all potential food safety concerns to the quality assurance manager.
Perform all other job duties as assigned.
Qualifications and Experience Requirements:
Previous ISO/GMP and in process testing experience
Excellent color detection skills and attention to detail
Measuring skills using calipers, micrometers, gauges, etc.
Computer skills such as Windows operating system, Microsoft Word, Excel, etc.
Ability to remain organized and problem solve.
Must be a team player and possess a "can do" attitude.
Ability to walk or stand for periods of time.
Excellent communication skills with the ability to read, write and communicate fluently in English.
Work Environment:
This position performs job duties located on the shop floor. This position walks through the manufacturing floor where machinery produces loud noises. In addition, this position will use quality assurance equipment, telephones/walkie-talkies to perform job duties.
Nearest Major Market: Cleveland
Nearest Secondary Market: Youngstown
Quality Assurance
Posted today
Job Viewed
Job Description
Internal Candidates Must Call HR Office and Speak with Verenice at (
Job Title : Quality
Department : Calhoun Distribution Center
Report To: Shift Supervisor
Mission Statement:
As a Mannington Associate I am expected to conduct myself in a manner which supports the company's values and philosophy, while performing in the best interest of my fellow associates. I am expected to contribute to our mission statement: to be the best people to do business within the flooring industry. Summary :
Ensures quantity and quality of products are accurate before shipping to the customer
Job Description:
* Verification of product labels to shipment requirements.
* Verification of product quantity to shipment requirements.
* Consolidation of multiple pallets within a single shipment.
* Report and log any errors found in the process.
Requirements:
* Candidate should have a basic understanding on how to operate a computer.
* Candidate must have experience freight checking.
* Candidate must be able to lift 30lbs to 50lbs repetitively.
* Candidate must be able to lift 100lbs occasionally.
* Candidate must be able to stand for duration of the shift.
Desired Qualifications:
* Proficient using SAP.
* Proficient with Microsoft Office programs (Word, Excel, Outlook)
Quality Assurance
Posted today
Job Viewed
Job Description
Quality Assurance
Birmingham, AL
1 year contract (could go longer)
Pay- $30-$36/HR
Mon - Fri
Daily duties:
- Operations Support provides support room clearance prior to and during manufacturing
- Review Production campaigns documentation for Products, Perform Batch Record review and final disposition of finished product.
- Review data and perform raw material and fill/finish component disposition
- Review clean room logbooks
- Review data to support the testing of site utilities (e.g. WFI, steam, nitrogen, etc.)
- Update, review and/or approval of QMS documentation in document control system (Regulus) e.g. SO P, work instructions, Forms, specifications
- Provide on-the-floor support during manufacturing campaigns
- Provide on-call support during Manufacturing Operation.
- Issuing product labels and perform label reconciliation
- SAP support, reviewing inspection plans, GMP monthly monitoring of the facility (labs, Manufacturing, warehouse)
- Additional task may be assigned based on experience and business need
Qualifications:
- Bachelor of Science degree in Chemistry, Biology, or Engineering.
- 1-3 years of Quality Assurance in a pharmaceutical or medical device manufacturing
- Manufacturing Or Lab environment
- Clean room experience
- Proficient computer skills, Microsoft Word, Excel, Access, SAP
- High attention to detail, organization, and accuracy
- Strong written and verbal communication skills
- Good interpersonal skills
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About Advantage TechnicalWith company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.
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