Clinical Data Standards Manager III
K3-Innovations, Inc.
We are seeking a highly experienced Data Standards Manager III to join our Clinical Data Reporting & Standards team. This role plays a critical leadership function in ensuring clinical data standards are consistently applied across studies, from data collection through regulatory submission. The ideal candidate is a subject matter expert in CDISC standards with strong communication skills and the ability to influence cross-functional teams. Key Responsibilities eCRF Design Critically review eCRF designs to ensure alignment with CDASH and SDTM standards Identify limitations in eCRF design and proactively collaborate with study teams to resolve issues SDTM Conformance & Mapping Create and review SDTM conformance mapping specifications using SDTM, TAUG, and AbbVie standards Support complex, study-specific data mapping to SDTM CDISC Validation Execute CDISC validation tools (e.g., Pinnacle 21) Partner with cross-functional teams to resolve validation issues and ensure appropriate documentation of unresolved findings (e.g., Clinical Study Data Reviewer’s Guides) Create and review Trial Design domains Maintain a clear understanding of end-to-end traceability from data collection through reporting Metadata Repository & Governance Manage CDISC-related metadata, terminology, and standards within the metadata repository Provide governance oversight to Data Standards Analysts and Senior Data Standards Analysts to ensure metadata consistency Standards Development & Governance Assist in the development and evolution of data standards Guide study teams on the appropriate use of AbbVie standards and best practices Cross-Functional Collaboration Represent the Clinical Data Reporting & Standards group across cross-functional initiatives Ensure industry and AbbVie standards are understood and followed Communication & Influence Clearly articulate clinical data standards concepts, regulatory guidance, and clinical principles Effectively present logical, persuasive arguments to programmers, statisticians, data scientists, clinical development, and regulatory stakeholders Diplomatically advocate for Data Standards priorities in cross-functional settings Qualifications MS with 8+ years of relevant clinical research experience OR BS with 12+ years of relevant experience Expert‑level knowledge of CDASH, SDTM, define.xml, and CDISC controlled terminology Proven experience mapping and converting legacy data into SDTM domains for eCTD submissions Minimum of two successful regulatory submissions with CDISC‑compliant data Strong understanding of international regulations and regulatory guidance related to clinical data standards Hands‑on experience with metadata repository technologies and data standards governance Why Join Us? This is an opportunity to make a meaningful impact on global clinical data standards while working remotely with a collaborative, highly skilled team. You’ll operate at a strategic level, influencing how clinical data is structured, governed, and delivered for regulatory success. #J-18808-Ljbffr K3-Innovations, Inc.
- A leading clinical data standards firm is seeking a highly experienced Data Standards Manager III to ensure clinical data standards are applied across studies. The ideal candidate will manage eCRF design, SDTM mapping, and validation processes, while guiding cross-functional...SuggestedRemote job
$145.2k - $217.88k
DescriptionThe Scientific Computing and Data team at the Icahn School of... ...data generated from the clinical care processes at the Mount... ...science. The Data Product Manager III is a senior technical specialist... ..., and success.Develop standards, processes and procedures for...SuggestedTraineeshipWork at officeLocal area$80k - $110k
...Clinical Data Management Role This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per... ...programming skills a plus ~ Experience with CDASH/CDISC standards preferred ~ Strong focus on flexibility, ability to...SuggestedTemporary workWork at officeFlexible hoursWeekend workAfternoon shift2 days per week1 day per week- ...Clinical Data Manager Job Title Clinical Data Manager Job Summary We are seeking a detail-oriented Clinical Data Manager to... ...accurate, complete, and compliant with applicable regulatory standards and Good Clinical Practice (GCP) guidelines. Key...SuggestedWork at officeFlexible hours
- A leading clinical research organization is seeking a Senior Lead Clinical Data Manager to drive data strategy and lead global clinical projects. This fully remote role offers flexibility and the chance to collaborate with top-tier sponsors. Candidates should have extensive...SuggestedRemote job
- Clinical Data Manager job at Pharmavise Corporation. New Jersey. This is a remote position. The Clinical Data Manager (CDM) is responsible for... ..., or protocol deviations. Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA,...Remote job
- ...gain access to decades of their health data in under 30 seconds, 100% free. All your... .... About the Role We are looking for a Clinical Data Manager to accelerate Novellia’s data curation... ...and investigating errors and developing standard operating procedures for Novellia’s QA/...Flexible hours
- Senior Lead Clinical Data Manager (Equivalent to project lead DM) Remote - US / Canada Join a Top 5 Global CRO at the forefront of data science in clinical trials. You’ll collaborate directly with leading pharma sponsors, gain exposure to diverse therapeutic areas, and...Remote work
$80k - $145k
A leading oncology research company is seeking a Clinical Data Manager/Sr to ensure the integrity of clinical trial data. The role involves... ...mindset, EDC experience, and an understanding of clinical data standards. This full-time position offers a salary range of $80,000-$...Remote jobFull time- Senior Lead Clinical Data Manager | CRO - FSP Remote - US | Permanent Are you ready to take your Clinical Data Management expertise to the... ...Management Plans (DMPs) aligned with GCP, SOPs, and regulatory standards. Drive proactive quality oversight, issue management, and...Permanent employmentRemote work
- The Cardiovascular Research Foundation is seeking a Junior Clinical Data Manager in New York, NY. This position focuses on ensuring the accuracy and timeliness of clinical study data while adhering to departmental SOPs. The ideal candidate will have strong organizational...
- Adams Clinical is seeking a Data Manager, Central Clinical Operations to lead data management across our multi-site network, ensuring data quality, governance, and operational visibility across eSource and EDC platforms. The role partners with site leadership to support...Remote job
- Payfuture Technologies is seeking a Linguist III for a remote role where you will develop annotation guidelines, collaborate with engineers, and analyze user traffic insights. The ideal candidate will have a Bachelor's degree in linguistics or a related field and proficiency...Remote job
- The Physicians' Group is seeking a Manager-Clinical Data Integrity in New York. This role involves providing training and guidance on coding compliance, managing the conversion of clinical documentation into data, and collaborating with departments to improve data integrity...
- ...science, health-related field, computer science, or a related discipline. Minimum of 7 years of hands on work experience in clinical data management within a pharmaceutical, biotechnology environment. Proficiency in at least one Electronic Data Capture (EDC) system (...16 hoursFull timeWork experience placementWork at officeRemote work
- Syneos Health/ inVentiv Health Commercial LLC is seeking a Clinical Scientist in Ophthalmology to develop medical plans and ensure regulatory... ...to gather necessary medical input. The ideal candidate will manage project milestones and deliverables while adhering to Good...Flexible hours
- Syneos Health/inVentiv Health Commercial LLC is seeking a Clinical Scientist in Ophthalmology to develop and execute medical plans, conduct medical data reviews, and collaborate with cross-functional teams to ensure compliance with regulations. This role involves engaging...Flexible hours
$130k - $155k
Principal Clinical Data Manager - REMOTE This position is posted by Jobgether on behalf of a partner company. We are currently looking for a... ...clinical trial data processes, ensuring compliance with industry standards and protocols. Your expertise will drive the delivery of...Remote jobWork from homeFlexible hours- ...leading global healthcare company is seeking an experienced Clinical Data Manager/Clinical Data Reviewer for a full-time, remote role. You... ...experience in a pharmaceutical environment, proficient in CDISC standards, and excels in communication and relationship-building....Remote jobFull time
$106.11k - $174.72k
...Street, New York, NY The Data Science Analyst III is a senior role, collaborating... ...on projects with the Clinical Command Center related to... ...clinical, contract, medical management, financial, administrative... ...tracked.Adheres to corporate standards for performance metrics,...Contract workTraineeshipLocal area- ...Clinical Data AnalystUnder the direction of the Director of the MSCH... ...personable and competent at managing relationships within the NICU... ...NICU clinical scenarios into standardized data points aligned with Vermont... ...experience in a Level III or Level IV NICU.Prior experience...Local areaImmediate startFlexible hours
- Thermo Fisher Scientific is seeking a Clinical Data Associate II to lead advanced data review and cleaning activities, ensuring data integrity... ...timeliness, and inspection readiness across studies. You will manage complex queries, review listings, and support CRF design...
$273.2k - $358.6k
...a visionary leader to shape and drive Clinical Data Science strategy across our global clinical... ...strategies and influence industry standards.Strategic Leadership:Define and execute... ...aligned with industry best practices.Risk Management & Problem Solving:Evaluate analytical...Full timeRemote work$149k - $160k
...healthcare works: applying 550+ proprietary clinical metrics across 80+ specialties to a... ...are seeking an exceptional AI-Native Data Analyst III to join our Reporting team. Our team delivers... ...our externally-facing relationship managers to address specific client questions...Work at officeWork visaFlexible hours3 days per week$39 - $41 per hour
A healthcare technology company in the United States seeks a Clinical Data Lead to manage quality tasks associated with data abstraction. This role involves mentoring new hires, conducting orientations, and overseeing quality assessments for clinical data. Candidates should...Remote jobHourly payFlexible hours$95.45k - $143.18k
...Mount Sinai Institute for Transformative Clinical Trials provides strategic leadership and... ...studies.Serving within an Academic CRO and Data and Clinical Coordinating Center... ...three (3) years of leadership experience managing regulatory affairs and safety operations...TraineeshipWork at officeLocal area- Plan, execute, and complete all data acquisition activities and... ...timely and effective manner Manage issue escalations using appropriate... ..., procedures, training, and standards Contribute to functional... ...BA) required, preferably in Clinical Data Management, Health, or Computer...
- ...staffing agency is partnering with a biotech firm to hire a Director of Clinical Data Management. This remote senior leadership role involves overseeing the Data Management department, ensuring high standards in clinical trial data. Candidates should have over 10 years of...Remote job
- ...partnering with a leading biotech client to hire a Director of Clinical Data Management. This is a senior leadership role reporting into the Head... ...clinical trial data is delivered with the highest standards of quality, compliance, and efficiency. Responsibilities...Full timeRemote work
$136.2k - $197.4k
Join to apply for the Manager of Clinical Data Management role at BioSpace 1 day ago Be among the first 25 applicants Join to apply for the... ...operational activities and DM processes like EDC, External data standardization, Collection, and Processing. Lead the efforts with...Permanent employmentFull timeTemporary workWork at officeLocal areaRelocation package
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Clinical Data Standards Manager III. Be the first to apply!
- psychiatry medical director New York, NY
- remote medical coding supervisor New York, NY
- clinical data manager remote New York, NY
- healthcare supervisor New York, NY
- mental health clinical supervisor New York, NY
- clinical program director New York, NY
- medical office supervisor New York, NY
- associate director clinical operations New York, NY
- medical coding manager New York, NY
- clinical operations director New York, NY


