clinical data manager

Parexel

<div><p><b>Job Summary:</b></p><p></p><p>
We are looking for a self-directed professional to support clinical data management efforts for the biomeasures endpoints projects. This individual will be responsible for acquiring, processing, and reviewing patient data and records, organizing clinical data forms, implementing data management plans including data preparation and validation activities and define ways to improve operational processes for these activities. They will act independently and in collaboration with study teams seeking to develop and validate novel digital endpoints across different therapeutic areas.</p><p></p><p>
In close partnership with colleagues from Research teams from Research and Development, They will play a key role in the deployment of novel digital endpoints into clinical studies, collection, management and analysis of sensor data, both in patients and healthy volunteers. This role will be central to the deployment and scaling of digital solutions into clinical trials where these technologies may be utilized as efficacy endpoints and provide value to key stakeholders including patients, physicians, payers.</p><p></p><p><b>
Key Responsibilities:</b></p><ul><li>
Data Management POC for studies in which we are included in</li><li>
Responsible for mapping local study dictionaries to CDISC Standards</li><li>
Participate and contribute to the development of operational plans to ensure data quality and completeness</li><li>
Develop, Implement, and Conduct data quality checks as needed for work/studies</li><li>
Work closely with the various stakeholders to understand evolving project portfolio needs, and integration into the systems and requirements; supporting studies with a wide range of disease domains</li><li>
Contribute technical expertise toward the design, implementation, and scaling up of sensor systems and analytics</li><li>
As a medical informaticist, ensure collection, organization, curation, storage and safeguarding of patient data from lab, asset teams, and external collaboration studies is consistent with 21CFR part 11</li><li>
Contribute to the overall architecture of the existing data pipelines and workflows, recommends and implements improvements</li><li>
Track emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality</li><li>
Manage own time to meet agreed targets</li><li>
Work under general supervision. Performs assignments using established procedures and general instruction</li><li>
Share learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications.</li></ul><p></p><p><b>
Minimum Requirements:</b></p><ul><li>
Master's degree in Health Informatics, Computer Science, Information Systems, or similar field required</li><li>
A minimum of 5+ years of technical experience required, including:</li><li>
Python</li><li>
Unix/Linux environments</li><li>
Version control systems (ex. Git)</li><li>
AWS or other cloud-based development</li><li>
Electronic data captures (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Rave</li><li>
Familiarity with pharmaceutical informatics standards like CDISC and MedDRA</li><li>
GCP experience</li><li>
Strong interpersonal and collaboration skills</li><li>
Demonstrate the ability to build consensus and be agile to changing circumstances and priorities</li><li>
Hands-on experience with Clinical Data Management, including Case Report Form (CRF) design, CRF annotation, database design, data collection, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, and regulatory requirements</li></ul><p></p><p>
#LI-CF1</p><br>
#LI-REMOTE</div>

Clinical Data Manager, Digital Medicine and Translational Imaging - FSP - East Coast US

People Science

<p>People Science is looking for a Data Manager to join our team. This is a unique opportunity to be a part of a small team who is looking to empower humanity with the tools and knowledge of science and medicine to improve ourselves, our communities, and our world by making research tools accessible and understandable.</p><p>The People Science proprietary technology, Chloe (Consumer Health Learning &amp; Organizing Ecosystem), is a consumer-friendly mobile app on the frontend, and a modular and configurable clinical research data management tool on the backend. It is designed for the purpose of engaging individual participants in the clinical research process from the comfort of their home by using their personal devices through active and passive data collection.</p><p><b>Job Summary</b><br/>The Data Manager will support the People Science research studies by executing the technical build, configuration, and maintenance of study databases. Reporting to the Senior Data Manager, this role is responsible for the hands-on delivery of data management tasks within the proprietary Chloe Platform. The Data Manager will ensure high standards of data integrity while managing project timelines and deliverables for assigned SaaS and SaaS+ studies.</p><p><b>Duties &amp; Responsibilities</b><br/><b>Data Management &amp; Technical Delivery</b></p><p>● Database Build &amp; Configuration: Execute the end-to-end build, configuration, and validation of study databases within the Chloe Platform based on approved specifications.</p><p>● System Validation: Perform and document User Acceptance Testing (UAT) and validation procedures to ensure database functionality aligns with protocol requirements.</p><p>● Maintenance: Provide ongoing maintenance of study databases, including the implementation of mid-study changes and system updates under the guidance of the Senior Data Manager.</p><p>● Documentation: Develop and maintain key study documentation, including Chloe build specifications, Edit Check Specifications, and Case Report Forms (CRFs).</p><p>● Data Integrity: Monitor incoming data for completeness and accuracy; identify data discrepancies and work with clinical teams to facilitate resolution.</p><p><b>Project Management &amp; Operations</b></p><p>● Project execution: Support the end-to-end execution of SaaS and SaaS+ study types, from initial hand-off through to study closeout. Manage the day-to-day operations of assigned studies to ensure deliverables are met according to the project plan and established timelines.</p><p>● Status Tracking: Track and report on study status, progress, and metrics to internal and external stakeholders.</p><p>● Compliance: Ensure all data management activities are conducted in compliance with SOPs, study protocols, and clinical research regulations.</p><p>● Meeting Support: Assist in preparing materials for client meetings and participate in Clinical Operations activities to ensure study alignment.</p><p><b>Cross-Functional Collaboration</b></p><p>● Internal Liaison: Coordinate with clinical operations and technology teams to ensure a seamless workflow within the Chloe Platform.</p><p>● Requirement Translation: Support the translation of client study objectives into specific technical configurations within the platform.</p><p>● Training Support: Assist in the development of study-specific workflows and help provide platform training to internal and external users.</p><p><b>Requirements and Skills</b></p><p>● Bachelor&rsquo;s degree in life sciences, data sciences, health sciences, or related field or equivalent work experience, preferred</p><p>● 3+ years of experience in clinical data management, ideally in decentralized studies</p><p>● Hands-on experience using clinical trial management systems (CTMS), EDC, or DCT platforms</p><p>● Knowledge of clinical research and clinical study processes</p><p>● Knowledge of GCP, FDA regulations, and ICH guidelines</p><p>● Strong organizational and communication skills, with a &ldquo;tech-savvy&rdquo; mindset, comfortable in a fast-paced environment</p><p><b>Preferred Skills</b></p><p>● Experience with decentralized and virtual study tools (eConsent, ePRO, eSource)</p><p>● Familiarity with User Acceptance Testing and software validation</p><p>● Demonstrated Project Management experience running multiple projects/studies at a time with high attention to detail</p><p><i>*VISA Sponsorship is NOT Available for this position.</i></p><p>We are a remote-first team, primarily based in the Los Angeles area.</p><p>Salary will depend on various factors including applicant's prior relevant job experience, skill set, and geographic location. People Science offers a benefit package for full-time employees which includes: Medical, Dental, Vision, Flexible Spending Account, Life Insurance, DepCare FSA, Flexible Vacation Time Policy, Holidays, Retirement saving opportunity, and Employee Stock Options. People Science reserves the right to amend, change, alter, and revise pay ranges and benefits offerings at any time. It is at the Company's discretion to determine what pay is provided to a candidate within the range associated with the role.</p><p><b>Who We Are</b><br/>www.peoplescience.health<br/>People Science is a direct-to-consumer scientific research company providing a scaled R&amp;D platform for alternative medicines. It is poised to revolutionize the alternative medicine landscape by empowering patients, consumers, providers, and scientists to collectively make discoveries using our research platform. We aim to be the leading tech-enabled research organization in this space. People Science is powered by our proprietary software technology called Chloe (Consumer Health Learning and Organizing Ecosystem), a consumer-friendly mobile app on the frontend, and a modular and configurable clinical research data management tool on the backend. Chloe is a cloud-based modular software platform built to make scaled clinical evidence generation easier and more affordable. It is designed for the purpose of engaging individual participants in the clinical research process by using their personal devices through active and passive data collection. People Science is building an infrastructure and science service model with long term value to humanity. We offer Chloe technology licensing as well as end-to-end clinical research services focusing on cannabinoids, microbiome interventions, supplements and nutraceuticals, natural and synthetic psychedelics, nutrition and &ldquo;food as medicines&rdquo;, and digital health solutions.</p><p>Job Type: Full-time</p><p>Pay: $80,000.00 - $115,000.00 per year</p><p>Benefits:</p><ul><li>Dental insurance</li><li>Flexible spending account</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Retirement plan</li><li>Vision insurance</li></ul><p>Application Question(s):</p><ul><li>What clinical trial management systems do you have hands-on experience with? </li></ul><p>Education:</p><ul><li>Bachelor's (Required)</li></ul><p>Experience:</p><ul><li>clinical data management: 3 years (Required)</li></ul><p>Work Location: Remote</p>

Data Manager (Clinical Research)

ICON plc

<div>Senior Program Manager, Clinical Data Review<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
What You Will Be Doing:</div><div></div><ul><li><div>
Lead clinical data review activities across assigned clinical studies or programs, ensuring medically meaningful interpretation of emerging efficacy and safety data.</div></li><li><div>
Perform comprehensive review of clinical data listings, patient profiles, and integrated datasets to identify clinically relevant trends, safety signals, protocol deviations, and potential data inconsistencies.</div></li><li><div>
Provide clinical oversight of data review outputs including safety data, laboratory results, vital signs, exposure, prohibited medications, efficacy endpoints, and adverse events.</div></li><li><div>
Identify potential safety signals or medically significant trends and collaborate with Pharmacovigilance, Clinical Science, and Medical Monitor teams to ensure appropriate evaluation and escalation.</div></li><li><div>
Serve as a clinical subject matter expert (SME) supporting ongoing data review during key study milestones including interim analyses, data cuts, regulatory submissions, and database locks.</div></li><li><div>
Collaborate cross-functionally with Clinical Science, Medical Monitors, Clinical Operations, Biostatistics, Pharmacovigilance, Data Management, and Programming to resolve clinically relevant data issues.</div></li><li><div>
Contributes to the development and implementation of standardized clinical data review frameworks, including review plans, flagging matrices, and escalation pathways.</div></li><li><div>
Support risk-based data review strategies aligned with RBQM principles to focus on clinically meaningful signals and patient safety indicators.</div></li><li><div>
Ensure inspection-ready documentation of clinical data review activities, decisions, and escalation pathways.</div></li><li><div>
Provide clinical input into data review listings, dashboards, and visualization tools to ensure outputs support meaningful medical interpretation.</div></li><li><div>
Lead or support cross-study and program-level data reviews, identifying trends across subjects, sites, and treatment arms.</div></li><li><div>
Participate in safety review meetings, clinical review forums, and data review working groups to communicate emerging findings.</div></li><li><div>
Maintain strong understanding of GCP, ICH guidelines, and regulatory expectations related to clinical data review and patient safety monitoring.</div></li></ul><div></div><div>
Your Profile:</div><div></div><ul><li><div>
Bachelor&rsquo;s degree required; Advanced degree (MS, PharmD, PhD, or MD) preferred in Life Sciences, Nursing, Pharmacy, or a related field</div></li><li><div>
Minimum of 5 years of experience in the pharmaceutical, biotechnology, or CRO industry, with a focus on clinical data review, clinical operations, or clinical science</div></li><li><div>
Demonstrated experience reviewing and interpreting clinical trial data (e.g., listings, patient profiles, safety and efficacy data) to identify trends, inconsistencies, and potential safety signals</div></li><li><div>
Strong understanding of clinical trial processes, including study conduct, data flow, and key milestones (interim analyses, database lock, regulatory submissions)</div></li><li><div>
Experience collaborating cross-functionally with teams such as Clinical Science, Medical Monitoring, Pharmacovigilance, Data Management, and Biostatistics</div></li><li><div>
Knowledge of GCP, ICH guidelines, and regulatory requirements related to clinical trials and patient safety monitoring</div></li><li><div>
Familiarity with risk-based monitoring (RBM/RBQM) principles and data review strategies preferred</div></li><li><div>
Medical coding experience (e.g., MedDRA, WHO Drug) preferred</div></li><li><div>
Ability to interpret complex clinical data and translate findings into clear, actionable insights for cross-functional stakeholders</div></li><li><div>
Strong analytical skills with high attention to detail and the ability to identify clinically meaningful patterns in large datasets</div></li><li><div>
Experience contributing to or developing data review plans, listings, dashboards, or visualization tools is preferred</div></li><li><div>
Excellent communication skills, with the ability to present clinical data findings in meetings, safety reviews, and cross-functional forums</div></li><li><div>
Proven ability to manage multiple studies or priorities in a fast-paced environment while maintaining quality and timelines</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Senior Program Manager, Clinical Data Review

NTT DATA

<div>At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here.<br>
<br>
For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing services and automation. With our industry-specific platforms, we deliver continuous value addition, and innovation that will improve your business outcomes. Outsourcing is not just a method of gaining a one-time cost advantage, but an effective strategy for gaining and maintaining competitive advantages when executed as part of an overall sourcing strategy.<br>
<br>
NTT DATA's Client is seeking a Manager Clinical Data Analytics to manage primary data and analytics support for assigned business unit, working closely with national and local leadership to drive clinical analytics relative to risk adjustment (Medicare HCC, Medicaid CDPS-Rx), Quality (HEDIS/STARS), risk stratification and population health initiatives. Provides subject matter expertise on statistical techniques, data mining, visualization and analysis, and is accountable for ensuring that analytics are timely, accurate and optimally prioritized to best meet business needs. Additional duties include providing necessary guidance and mentoring to teams and preparing executive summaries for national and local leadership. Will display persuasive data visualization and effective oral and written communication skills that can translate complex analytic findings and concepts to a varied audience of users.<br>
<br>
<b>Daily Responsibilities</b> Oversees analytical support for local health plan or business unit. Uses subject matter expertise and data / analytics to support strategic decision making.<br>
<ul><li>Provides subject matter expertise for one or more of the following: Risk Adjustment for CMS HCC Medicare Advantage and/or Medicaid (CDPS Rx, Milliman, Mercer), Quality (HEDIS / STARS) measure performance, Population Health including population segmentation, risk stratification models, disease management and case management performance tracking and analytics.</li><li>Partners with clinical leaders at the national and local plan level to drive trending and operational analytics of program impact; ensures leaders have a clear and timely view of performance and emerging risks in their population.</li><li>Responsible for identifying improvement opportunities for clinical initiatives through reporting and analytics; operates as a thought leader.</li><li>Drives changes and enhancements to analytic capabilities, continuously improves actionable intelligence derived from data and strives to provide elastic and scalable efficiencies on team analytic products.</li><li>Maintains ownership of clinical initiative operational metrics, outcome metrics, intervention efficacy analyses and is comfortable managing teams of business analysts and data scientists, harnessing their expertise to produce dashboards and automated solutions to enable health plans and business units to manage their population rapidly and effectively.</li><li>Provides oversight and direction to employees; delegates effectively to meet overall team goals and foster individual employee development. Creates a spirit of teamwork and collaboration both within the team and across matrix business units.</li><li>Provides coaching, mentoring and development opportunities to staff as well as effective performance feedback. Utilizes SQL, AWS, Hadoop, Tableau, Qlik and other BI and data tools to define, extract, validate, shape and interpret data to meet business needs. Accountable for the accuracy of work product for the team.</li><li>Coordinates efforts with Informatics, Information Technology and other teams to promote data &quot;best practices &quot; across sites, and problem solves data acquisition, design and quality issues.</li></ul><br>
<b>
Required Skills</b> Undergraduate degree ideally in a quantitative field such as Mathematics, Computer Science or related degree.<br>
<ul><li>7+ years of direct, relevant experience.</li><li>3+ years of management experience or equivalent demonstrated leadership skills.</li><li>Experienced in an analytics environment or field (epidemiology, biostatistics, economics, healthcare, other).</li><li>Excellent verbal and written communication skills.</li><li>Ability to develop and lead staff in a team-oriented environment.</li><li>Ability to forge effective business relationships across functional groups and levels.</li><li>Experience working as a liaison between technical and non-technical groups.</li><li>Strong analytical and problem solving skills; ability to drive results and deliver on multiple tasks.</li><li>MS Suite power user; Expert level knowledge of SQL, Qlikview, Tableau or similar business intelligence tools.</li></ul><br>
About NTT DATA Services:<br>
<br>
NTT DATA Services is a recognized leader in IT and business services, including cloud, data and applications, headquartered in Texas. As part of NTT DATA, a $30 billion trusted global innovator with a combined global reach of over 80 countries, we help clients transform through business and technology consulting, industry and digital solutions, applications development and management, managed edge-to-cloud infrastructure services, BPO, systems integration and global data centers. We are committed to our clients' long-term success. Visit nttdata.com or LinkedIn to learn more.<br>
<br>
NTT DATA Services is an equal opportunity employer and considers all applicants without regarding to race, color, religion, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other characteristic protected by law. We are committed to creating a diverse and inclusive environment for all employees. If you need assistance or an accommodation due to a disability, please inform your recruiter so that we may connect you with the appropriate team.<br>
<br>
Where required by law, NTT DATA provides a reasonable range of compensation for specific roles. The starting hourly range for this remote role is <b>($60.00 - $70.00/hourly )</b>. This range reflects the minimum and maximum target compensation for the position across all US locations. Actual compensation will depend on several factors, including the candidate's actual work location, relevant experience, technical skills, and other qualifications.<br>
<br>
This position is eligible for company benefits that will depend on the nature of the role offered. Company benefits may include medical, dental, and vision insurance, flexible spending or health savings account, life, and AD&amp;D insurance, short-and long-term disability coverage, paid time off, employee assistance, participation in a 401k program with company match, and additional voluntary or legally required benefits.</div>

Manager Clinical Data Analytics

bioMerieux

<div><p>Position Summary<br>
The Global Medical Affairs Biostatistics and Data Management team plays a central role in ensuring high-quality, reliable data supports evidence generation, regulatory submissions, and post‑market activities. We are seeking a highly skilled and motivated Data Manager to establish foundational data management processes, workflows, and SOPs within Global Medical Affairs. The Data Manager will independently lead data management activities from study planning through database lock; collaborates with Disease State Science, Clinical Research Science, Biostatistics, and external vendors; ensures high-quality data delivery for global evidence-generation studies.</p><p>
Primary Duties</p><ul><li>
Lead end-to-end data management for Medical Affairs evidence-generation projects from start-up through database lock.</li><li>
Develop and maintain data standards, data dictionaries, and controlled terminologies for consistency across studies.</li><li>
Author Data Management Plans (DMPs), CRF/eCRF specifications, and edit checks/validation plans.</li><li>
Ensure compliant data collection, handling, and privacy aligned with GCP, GDPR, and HIPAA.</li><li>
Manage data vendors and EDC providers (e.g., Medrio, REDCap, Castor, Rave), including UAT and system configuration.</li><li>
Perform ongoing data review, discrepancy management, and reconciliation with external data sources.</li><li>
Collaborate with data engineers for automated data pipeline development.</li><li>
Define and manage data transfer specifications and secure data pipelines with IT/Data Engineering.</li><li>
Track timelines/metrics, drive issue resolution, and communicate risks and mitigations to stakeholders.</li><li>
Deliver clean, analysis-ready datasets to Biostatistics for reports, publications, and dashboards.</li><li>
Support audit/inspection readiness, documentation, and CAPA as needed.</li><li>
Contribute to process optimization and templates to scale the GMA data management function.</li><li>
Champion data integrity, traceability, and documentation across all study artifacts.</li><li>
Collaborate cross-functionally (Medical, Clinical Ops, Regulatory, Quality) to align on study objectives and data needs.</li><li>
Perform all work in compliance with company quality procedures and standards.</li><li>
Perform other duties as assigned.</li></ul><p><br>
Qualifications<br>
Required Education, Training, and Experience</p><ul><li>
Master's degree required (Life Sciences, Statistics, Public Health, Health Informatics, or related field).</li><li>
5+ years of professional related experience with clinical data management experience (Medical Affairs/observational preferred).<ul><li>
Experience with EDC systems and SOP development (Medrio, REDCap, Castor, or Rave; DMP/SOP authoring)</li></ul></li></ul><p>
Preferred</p><ul><li>
Experience with real‑world evidence (RWE), registries, or post-market clinical studies.</li><li>
Experience in the medical device/diagnostics industry.</li><li>
Proficiency with MedDRA and WHODrug coding.</li><li>
Vendor oversight experience.</li><li>
Familiarity with biostatistics workflows and analysis‑ready data structures.</li></ul><p><br>
Knowledge, Skills, and Abilities (KSA)</p><ul><li>
Consistently upholds and reflects the core ethical principles and values that bioM&eacute;rieux promotes.</li><li>
Written communications, including the ability to communicate technical data in written form.</li><li>
Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.</li><li>
Analyze data and make decisions/recommendations using data to guide decision-making and provide suggestions for improvement.</li><li>
Driving continuous improvement by evaluating processes and implementing necessary changes.</li><li>
Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives.</li><li>
Skilled in MS Office tools including Outlook, Teams, Word, and Excel; advanced skill level.</li><li>
EDC design/configuration; data validation planning; query management; coding; UAT/system testing; data transfer specifications; documentation control.</li><li>
Knowledge of GCP, GDPR, HIPAA; audit readiness; CAPA management; risk and issue tracking.</li><li>
Ability to manage competing deadlines; support publications and dashboards with Biostats.</li></ul><p>
Supplemental Data</p><ul><li>
Primary systems: Medrio, REDCap, Castor, or Rave; ePRO/eCOA platforms; code lists (MedDRA, WHODrug).</li><li>
File formats &amp; integrations include CSV/TSV, SAS XPT, and API‑based transfers; secure data repositories.</li></ul><p>
Working Conditions &amp; Physical Requirements</p><ul><li>
Ability to remain in a stationary position (sitting or standing) for prolonged periods.<br>
Ability to ascend/descend stairs, ladders, ramps.<br>
Standard office environment with extended screen time.<br>
Ability to attend early/late global meetings.<br>
No PPE requirement.<br>
No heavy lifting or machinery operation required.</li></ul><p>
Travel Requirements</p><ul><li>
Domestic travel: 5%<br>
International travel: 0</li></ul><div>
The estimated salary range for this role is between $115,000-160,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux&rsquo;s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate&rsquo;s experience and will be presented in writing at the time of the offer.</div><div>
In addition, bioM&eacute;rieux offers a competitive Total Rewards package that may include:</div><ul><li>A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options</li><li>Company-Provided Life and Accidental Death Insurance</li><li>Short and Long-Term Disability Insurance</li><li>Retirement Plan including a generous non-discretionary employer contribution and employer match.</li><li>Adoption Assistance</li><li>Wellness Programs</li><li>Employee Assistance Program</li><li>Commuter Benefits</li><li>Various voluntary benefit offerings</li><li>Discount programs</li><li>Parental leaves</li></ul><div>
</div><div>
#LI-US</div></div><p></p>

Data Manager

AMR Clinical

<div><p>Data Management Specialist manages data entry from the source documents into CRF&rsquo;s. Specialists collaborate with the clinical study team to take a pro-active approach to identify issues regarding data collection. Data Management Specialist completes data forms and queries in the specified timelines.</p><p></p><p><i><br>
To consistently embody AMR Clinical&rsquo;s Core Values:</i></p><ul><li><i>
United We Achieve</i></li><li><i>
Celebrate Diverse Perspectives</i></li><li><i>
Do the Right Thing</i></li><li><i>
Adapt and Persevere</i></li></ul><p>
The Data Management Specialist reports to the Clinical Data Manager.</p><p>
Classification: Non-Exempt</p><p><b>
Primary Responsibilities:</b></p><ul><li>
Ensure Compliance with Regulatory &amp; Sponsor Requirements &ndash; Adhere to ICH-GCP, FDA, and sponsor-specific requirements for data management and documentation.</li><li>
Monitor Data Trends &amp; Report Deviations &ndash; Identify patterns in data entry errors and escalate potential protocol deviations or systemic issues to the appropriate team members.</li><li>
Collaborate with Study Teams for Query Resolution &ndash; Work proactively with CRC, QA, and monitors to address open queries and improve data accuracy.</li><li>
Assist in Preparing Sites for Audits &amp; Monitoring Visits &ndash; Ensure data reconciliation, regulatory compliance, and complete documentation before external reviews.</li><li>
Contribute to Study Start-Up &amp; Closeout Activities &ndash; Assist in database lock procedures, final query resolution, and archiving of study records.</li><li>
Ensure timely and accurate CRF completion for each study subject.</li><li>
Review data entered to ensure accuracy</li><li>
Complete CRF data entry in a timely basis according to specified timeline per the protocol.</li><li>
Review source documents for accuracy</li><li>
Maintain source document and logs throughout the study</li><li>
Upload documents into eSource</li><li>
Confirm proper randomization procedures are followed.</li><li>
Schedule and assist with on-site monitor visits.</li><li>
Submit internal queries to clinical staff as needed.</li><li>
Attend site initiation visits for current assigned protocols.</li><li>
Assist with requests from monitors and auditors for completed CRF&rsquo;s and patient records.</li><li>
Develop rapport and maintain professional communication with team members, subjects, sponsors, monitors, etc.</li><li>
Identify trends and systematic issues, escalate to CRC and QA.</li><li>
Complete protocol specific, eSource training as applicable</li><li>
Work with coordinator to complete SAE information if CRF is used in reporting.</li><li>
At study closure, ensure all CRF&rsquo;s are completed, and all data entered as appropriate.</li><li>
Position may require occasional weekend and/or overtime hours.</li><li>
Other duties as assigned</li></ul><p></p><p><b><br>
Desired Skills and Qualifications:</b></p><ul><li>
Proficiency in managing confidential and sensitive information with discretion.</li><li>
Strong analytical and problem-solving skills with attention to detail.</li><li>
Experience with data entry programs preferred.</li><li>
Ability to learn and be proficient in various web-based data entry programs.</li><li>
Advance knowledge in operating office equipment and software programs</li><li>
Excellent verbal and written communication skills.</li><li>
Strong interpersonal skills</li><li>
Strong multi-tasking skills and organizational skills</li><li>
Attention to detail</li><li>
Motivated, self starter, and exercises initiative.</li><li>
Excellent follow-up skills.</li><li>
Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.</li><li>
Fluent in English.</li></ul><p></p><p><i><br>
AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.</i></p><p><i>
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.</i></p></div><p></p>

Data Management Specialist

Nationwide Children's Hospital

<div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div>Overview:</div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div></div><div><br>
Full time, 40 hours per week. Day shift, M-F 8a-5p. No weekends or holidays requirement.</div><div>
Remote opportunity for work after the initial 90 orientation/probationary period.</div><div></div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><br>
Job Description Summary:</div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><br>
<div></div>
Collects in-patient clinical data for/but not limited to The Children&rsquo;s Hospital Neonatal Consortium (CHNC) database data set; VON database data set; Small Baby Database data set; RedCap BPD Database data set. Insures accurate recording of all databases data elements and entry of that data into the Web-based data entry system. Monitors changes needed for all Databases and communicates with Site Physician Sponsor for additions and corrects.<div></div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><br>
Job Description:</div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div></div><div><br>
Essential Functions:</div><div></div><ul><li>
Acts as Site Representative to the CHNC_DATA Team.</li><li>
Trains and oversees data management staff.</li><li>
Establishes an electronic system for filing and storing of forms to ensure integrity of data submitted.</li><li>
Establishes procedures for data security and patient privacy.</li><li>
Ensures staff completion of inter-rater reliability and interact with CHND Project Manager regarding results as instructed by the CHND Data Integrity Team at CHNC.</li><li>
Establishes procedures for data collection, submission, and correction. Complete and overs data collection and data entry carefully and accurately as per site&rsquo;s protocol and Manual of Operations definitions.</li><li>
Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management; documents and required observations for source documents as required by the protocol.</li></ul><div></div><div><br>
Education Requirement:</div><div>
Graduate of an approved school/college of nursing and licensed for practice as a registered nurse in the State of Ohio; BS/BSN, preferred.</div><div><br>
Licensure Requirement:</div><div>
(not specified)</div><div><br>
Certifications:</div><div>
(not specified)</div><div><br>
Skills:</div><ul><li>
Working knowledge of PCs and word processing and data management software.</li><li>
Verbal and written communication.</li><li>
Goal-oriented; self-directive.</li><li>
Initiation, motivation, and creativity.</li><li>
Organizational and interpersonal skills.</li><li>
Understanding of medical terminology and clinical trials, preferred.</li></ul><div><br>
Experience:</div><div>
 5 years in a clinical healthcare role required, with experience in a tertiary NICU or ICU, required.</div><div><br>
Physical Requirements:</div><div>
OCCASIONALLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Climb stairs/ladder, Cold Temperatures, Color vision, Communicable Diseases and/or Pathogens, Depth perception, Driving motor vehicles (work required) *additional testing may be required, Electricity, Flexing/extending of neck, Fume /Gases /Vapors, Hand use: grasping, gripping, turning, Hot Temperatures, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Lifting / Carrying: 41-60 lbs, Lifting / Carrying: 61-100 lbs, Loud Noises, Patient Equipment, Peripheral vision, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 100 lbs or greater with assistance, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Reaching above shoulder, Seeing &ndash; Far/near, Squat/kneel, Standing</div><div>
FREQUENTLY: Decision Making, Interpreting Data, Problem solving, Walking</div><div>
CONTINUOUSLY: Audible speech, Computer skills, Hearing acuity, Repetitive hand/arm use, Sitting</div><div><br>
Additional Physical Requirements performed but not listed above:</div><div>
(not specified)</div><div></div><div><br>
&quot;The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet&quot;</div></div>

Clinical Data Coordinator RN Exempt

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