clinical data specialist

Celerion

<div><div>Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. 
</div><div></div> 
<div>Responsible for the review of all source data and ensure all applicable data is entered into its respective database and/or Case Report Form (CRF). Ensure the completeness, accuracy, and consistency of source data and CRF data entry so that it meets the standard of quality expected for reporting to Sponsors and regulatory bodies. Participate with auxiliary teams involved in study set up, conduct, and data cleaning of clinical trials.</div>
<h3 class="jobSectionHeader">Essential Functions</h3><ul><li>
Attend study setup meetings to determine QC criteria and timelines for each study</li><li>
Review study-specific source documents to ensure all forms are accurate prior to study start and that all data collected is in accordance with study-specific Case Report Forms and protocol requirements.</li><li>
Ensure QC reviews are complete in accordance with study-specific timelines</li><li>
Review source data on an ongoing basis to ensure the following: Clinical source data is complete according to GCP and FDA guidelines, protocol deviations (if applicable) are documented, and source data is collected in accordance with Sponsor requirements, and Celerion SOPs/PGs. Ensure data corrections are completed according to GCP guidelines, and Celerion SOPs/PGs. Complete a Final QC to ensure all source data is accounted for and has been QC reviewed</li><li>
Perform accurate data entry and verification for Celerion Standard and Sponsor Provided EDCs.</li><li>
Archive source documentation including CRFs</li><li>
Complete QC/DE dedicated milestones in a timely manner</li><li>
Perform standard quality control steps</li></ul><h3 class="jobSectionHeader">
Requirements</h3><ul><li>
High School Diploma or GED (relevant internal Celerion experience in lieu preferred)</li><li>
1 - 2 years industry experience preferred</li><li>
Previous Quality Control/ Data Entry or related experience preferred</li><li>
Medical Terminology Training preferred</li><li>
Excellent oral and written communication skills</li><li>
Ability to organize and manage multiple priorities</li><li>
Experience working in an environment with complex processes and defined criteria</li><li>
Excellent time management skills required</li><li>
Proficient in MS Office applications required</li><li>
Excellent attention to detail skills required</li></ul><div>
Celerion Values: Integrity Trust Teamwork Respect</div><div></div><div> 
Are you ready to join our team?</div><div></div><div> 
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.</div>

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.</div>

Clinical Data Specialist

Alaka`ina Foundation Family of Companies

<div><div>The Alaka`ina Foundation Family of Companies (FOCs) is possibly looking for a Military Working Dog Trauma Registry Clinical Data Specialist to provide support for our government customer in San Antonio, TX. *****This is a 100% Remote position with some travel required.*****
DESCRIPTION OF RESPONSIBILITIES:<ul><li>
Collect comprehensive, accurate data relating to military working dog (MWD) trauma and Disease Non-Battle Injury patients in operational and operational training environments by abstracting all trajectories of care, verify and update all information compiled and enter data into the Registry in a timely manner, perform coding of injuries, procedures, and causes of injuries using standard medical record references, specifically International Classification of Diseases (ICD)-9/10 codes or similar codes for MWD (such as SNOMED CT), assign diagnoses Abbreviated Injury Scale (AIS) and ICD-9/10-CM codes, and complete Injury Severity Score (ISS) as applicable and other trauma score calculations equal to or greater than an average of 12 records per week, maintaining a 90% Accuracy Rate as directed.</li><li>
Utilize Abstracting Business Rules as described in data abstraction resources.</li><li>
Serve as SME for MWD injury and procedure coding for registry customers.</li><li>
Assist PM with quality assurance evaluations for clinical accuracy of Registry data at all Roles of Care, maintaining a 90% Accuracy Rate as directed.</li><li>
Review government provided data sources to enter canine data on injury, treatment, medications, transportation and complications on injured and diseased Military Working Dogs (MWD). The data will be abstracted into the Military Working Dog Trauma Registry (MWDTR), part of the Department of Defense Trauma Registry suite of registries. 
Assists with development of presentations, reports, data analytics using DoD MWD Trauma Registry data and patient records to support Performance Improvement Monitoring. Provides a monthly report to DHA Veterinary Services staff on progress of abstracting data into the registry, including identification of gaps in registry data (e.g., incomplete records, missing records or data sources, etc.).</li></ul> 
REQUIRED DEGREE/EDUCATION/CERTIFICATIONS:
Bachelor&rsquo;s degree in comparable fields of study with 4 years&rsquo; experience in a related field; 
REQUIRED SKILLS AND EXPERIENCE:<ul><li>
Proficiency in medical terminology is required.</li><li>
Veterinary experience (veterinary assistant or technician) is required.</li><li>
Must possess computer skills preferably but not limited to the following computer software programs: Microsoft Office &ndash; Word, Excel, Access and PowerPoint, and virtual platforms such as Adobe Connect, Microsoft Teams and SharePoint.</li><li>
Experience in a human or canine trauma registry is strongly preferred.</li><li>
Military experience working with canines and/or military veterinary medicine experience is preferred.</li><li>
Must be able to read, write and speak English.</li></ul> 
REQUIRED CITIZENSHIP AND CLEARANCE:<ul><li>
Must be a U.S. Citizen.</li><li>
Must have Active Secret Clearance</li></ul> 
The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.
We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees
&ldquo;EOE, including Disability/Vets&rdquo; OR &ldquo;Equal Opportunity Employer, including Disability/Veterans&rdquo;
The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kapili Services, Po`okela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science &amp; technology, and environmental stewardship.
For additional information, please visit www.alakainafoundation.com 
#LI-JS1 
#ClearanceJobs</div></div>

Military Working Dog Trauma Registry Clinical Data Specialist

DEVX

Clinical Research Procedures &amp; Documentation SpecialistMedical Device &ndash; Orthopedics Required Contract Role Through End of 2026 (Potential Extension)Position OverviewWe are seeking an experienced Clinical Research Procedures &amp; Documentation Specialist with direct experience supporting orthopedic medical device clinical trials.This role is focused on clinical study execution processes, SOP development, and work instruction writing within orthopedic device studies. The selected candidate will work closely with Clinical Operations, Biostatistics, and Data Management teams to revise and harmonize clinical procedures to reflect real-world orthopedic study execution workflows.This is not a medical writing role (CER/PMCF/PMS).Key Responsibilities<ul><li>Collaborate with Clinical Operations SMEs to review and update clinical research procedures specific to orthopedic device studies</li><li>Draft, redline, and finalize SOPs and work instructions that govern study execution activities</li><li>Ensure procedures align with actual orthopedic trial workflows (site start-up, enrollment, device accountability, monitoring, close-out)</li><li>Facilitate cross-functional discussions to gather feedback and drive alignment</li><li>Develop and manage project timelines to keep procedural updates on track</li><li>Route finalized documents through appropriate document management and approval systems</li><li>Support inspection readiness and ensure compliance with FDA, ICH-GCP, and applicable medical device regulations</li><li>Contribute to procedural harmonization initiatives related to organizational changes</li></ul>Required Qualifications<ul><li>Minimum 5+ years of experience in clinical research within the medical device industry</li><li>Direct experience supporting or managing orthopedic device clinical trials</li><li>Demonstrated experience drafting or revising:</li><li>Clinical Operations SOPs</li><li>Work Instructions</li><li>Study execution processes</li><li>Strong understanding of the orthopedic device study lifecycle (start-up through close-out)</li><li>Experience working cross-functionally with Clinical Operations teams</li><li>Experience using document management systems and routing documents for approval</li><li>Strong organizational and project coordination skills</li></ul>Preferred Qualifications<ul><li>Experience with joint replacement, spine, trauma, or sports medicine device trials</li><li>Experience supporting audit and inspection readiness</li><li>Familiarity with FDA and MDR requirements for orthopedic devices</li><li>Experience in change management or procedural harmonization initiatives</li></ul>This Role Is Not:<ul><li>Not a CER / PMCF / PMS medical writing role</li><li>Not a site-only CRC position</li><li>Not a pharmacovigilance-only position</li></ul>Job Type: ContractPay: $34.39 - $41.41 per hourExpected hours: 40 per weekWork Location: Remote

Clinical Research Procedures & Documentation Specialist

Accenture

Skill required: Clinical Data Services - Clinical Database Programming 
Designation: Clinical Data Svs Analyst 
Qualifications:BE/MSc
 
Years of Experience:3 to 5 years
 
About Accenture 
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song&mdash; all powered by the world&rsquo;s largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
 
What would you do? You will be aligned with our Life Sciences R&amp;D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance &amp; Regulatory, helping the world&acirc;&euro;&trade;s leading biopharma companies bring their vision to life &acirc;&euro;&ldquo; enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Clinical Data Services involve the management and processing of data collected during clinical trials. This includes data collection, validation, storage, and analysis to ensure the data is accurate and reliable. The goal is to support clinical research by providing high-quality data that can be used to evaluate the safety and efficacy of medical treatments. These services are essential for regulatory compliance and successful trial outcomes. They often utilize specialized software and systems to manage the data efficiently. Develop and review complex edit checks, patient profile listings, reports, preprocessing checks &amp; map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. 
What are we looking for? &bull;Clinical Data Management &bull;Clinical Database Testing &bull;Clinical EDC Build &bull;Clinical EDC Design &bull;Ability to establish strong client relationship &bull;Ability to handle disputes &bull;Ability to manage multiple stakeholders
 
Roles and Responsibilities: &bull;In this role you are required to do analysis and solving of lower-complexity problems &bull; Your day to day interaction is with peers within Accenture before updating supervisors &bull; In this role you may have limited exposure with clients and/or Accenture management &bull; You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments &bull; The decisions you make impact your own work and may impact the work of others &bull; You will be an individual contributor as a part of a team, with a focused scope of work &bull; Please note that this role may require you to work in rotational shifts
 
BE,MSc

Clinical Data Svs Analyst

Skill required: Clinical Data Services - Clinical Database Programming 
Designation: Clinical Data Svs Sr Analyst 
Qualifications:BE
 
Years of Experience:5 to 8 years
 
About Accenture 
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song&mdash; all powered by the world&rsquo;s largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
 
What would you do? You will be aligned with our Life Sciences R&amp;D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance &amp; Regulatory, helping the world&acirc;&euro;&trade;s leading biopharma companies bring their vision to life &acirc;&euro;&ldquo; enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Clinical Data Services involve the management and processing of data collected during clinical trials. This includes data collection, validation, storage, and analysis to ensure the data is accurate and reliable. The goal is to support clinical research by providing high-quality data that can be used to evaluate the safety and efficacy of medical treatments. These services are essential for regulatory compliance and successful trial outcomes. They often utilize specialized software and systems to manage the data efficiently. Develop and review complex edit checks, patient profile listings, reports, preprocessing checks &amp; map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. 
What are we looking for? &bull;Clinical Data Management &bull;Clinical EDC Design &bull;Clinical EDC Build &bull;Adaptable and flexible &bull;Ability to perform under pressure &bull;Problem-solving skills
 
Roles and Responsibilities: &bull;In this role you are required to do analysis and solving of increasingly complex problems &bull; Your day to day interactions are with peers within Accenture &bull; You are likely to have some interaction with clients and/or Accenture management &bull; You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments &bull; Decisions that are made by you impact your own work and may impact the work of others &bull; In this role you would be an individual contributor and/or oversee a small work effort and/or team &bull; Please note that this role may require you to work in rotational shifts
 
BE

Clinical Data Svs Sr Analyst

Optum

<div>Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start Caring. Connecting. Growing together. 
Primary Responsibilities:<ul><li>
Serve as a laboratory and microbiology subject matter expert for related lab/microbiology related questions within the company</li><li>
Support technical teams within the organization by providing specifications on how to manage/map/transfer clinical data elements</li><li>
Participate in ETL development through the production of written specifications to engineering teams 
Perform custom source to target mapping of coded and un-coded data from customer's clinical (EMR's) and financial (claims) data to both industry standards and proprietary coding systems</li><li>
Perform standardization of additional data elements including but not limited to units of measurement, free text results and numeric assessments</li><li>
Utilize clinical knowledge to collaborate with life science customers and translate their needs to actionable business requirements</li><li>
Manage crosswalks between industry standards and internal identifiers</li><li>
Perform investigations of clinical data issues, identify root cause and trouble shoot. Including but not limited to laboratory and microbiology datasets</li><li>
Collaborate with internal engineering teams to develop mapping solutions</li><li>
Support product release work and scheduled updates including resolving mapping issues</li><li>
Work closely with other clinical informatics specialists in knowledge representation areas</li><li>
Ability to work creatively and flexibly, both independently and as part of a team</li><li>
Desire and ability to learn new skills, systems, and processes</li><li>
Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regard to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so</li></ul>
Required Qualifications:<ul><li>
Graduate degree or equivalent experience</li><li>
Bachelor's degree in biology, laboratory sciences, or healthcare</li><li>
2+ years direct patient care clinical experience</li><li>
2+ years of work experience with clinical data in EMR (Electronic Medical Records) or Claims</li><li>
1+ years experience mapping source data to target system</li><li>
ASCP Board of Certification (BOC) or equivalent certification</li><li>
Experience working with EMR and claimed data. Backend experience preferred, both backend and frontend ideal</li><li>
Familiarity with industry-standard medical coding. Including at least one of the following: NDC, RXNorm, Loinc, SNOMED, CPT, ICD-10, or HCPCS</li><li>
Proficiency in SQL and Regular expression (REGEX)</li><li>
Familiarity with big data and cloud technologies</li><li>
Demonstrated ability to perform tasks and adhere to timeframes within a project plan
</li><li>Demonstrated ability to independently analyze and summarize laboratory data issues</li><li>
Demonstrated solid ability to communicate technical information to a variety of audiences, including non-technical and technical individuals, using verbal and written communication</li></ul> 
At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone - of every race, gender, sexuality, age, location and income - deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.</div>

Senior Data Analyst

Washington University in St. Louis

<div><h1 class="jobSectionHeader">Scheduled Hours</h1>
40<h1 class="jobSectionHeader">
Position Summary</h1>
Collect and process behavioral evaluations, standardized videos, and motor exams during clinical appointments for the Movement Disorders Center.<h1 class="jobSectionHeader">
Job Description</h1><div><div><div><div><div><div><div>
Primary Duties &amp; Responsibilities:
</div></div></div></div></div></div></div><ul><li>Maintains and updates computer database of behavioral testing data; logs forms received and files as appropriate; prepares reports from database to include weekly reports and other reports as requested.</li><li>
Receives and disseminates study-related regulatory documents and correspondence; assists in screening documents for completeness and compliance with protocol and appropriate regulations; assists in investigating incomplete, inaccurate or missing documents to ensure accuracy and completeness of data.</li><li>
Communicates and coordinates with other study personnel as required to include MRI studies, and others as needed for study implementation and routine problem resolution.</li><li>
Attends routine meetings and other meetings related to the clinical research; stays abreast of information and any changes to study protocol.</li></ul>
Working Conditions:
Job Location/Working Conditions:<ul><li>
Normal office environment.</li></ul>
Physical Effort:<ul><li>
Typically sitting at desk or table.</li><li>
Repetitive wrist, hand or finger movement.</li></ul>
Equipment:<ul><li>
Office equipment.</li></ul>
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.<h1 class="jobSectionHeader">
Required Qualifications</h1>
Education:
High school diploma or equivalent high school certification or combination of education and/or experience. 
Certifications/Professional Licenses:
No specific certification/professional license is required for this position. 
Work Experience:
Customer Service (1 Year) 
Skills:
Not Applicable 
Driver's License:
A driver's license is not required for this position.<h1 class="jobSectionHeader">
More About This Job</h1>
WashU seeks highly motivated individuals who are able to perform duties in a manner consistent with our core mission and guiding principles.<h1 class="jobSectionHeader">
Preferred Qualifications</h1>
Education:
No additional education unless stated elsewhere in the job posting. 
Certifications/Professional Licenses:
No additional certification/professional licenses unless stated elsewhere in the job posting. 
Work Experience:
Medical Customer Service (1 Year)
Skills:
Detail-Oriented, Information Organization, Interpersonal Communication<h1 class="jobSectionHeader">
Grade</h1>
C06-H<h1 class="jobSectionHeader">
Salary Range</h1>
$17.34 - $25.40 / Hourly
The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.<h1 class="jobSectionHeader">
Questions</h1>
For frequently asked questions about the application process, please refer to our External Applicant FAQ.<h1 class="jobSectionHeader">
Accommodation</h1>
If you are unable to use our online application system and would like an accommodation, please email CandidateQuestions@wustl.edu or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.
All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.<h1 class="jobSectionHeader">
Pre-Employment Screening</h1>
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.<h1 class="jobSectionHeader">
Benefits Statement</h1>
Personal<ul><li>
Up to 22 days of vacation, 10 recognized holidays, and sick time.</li><li>
Competitive health insurance packages with priority appointments and lower copays/coinsurance.</li><li>
Take advantage of our free Metro transit U-Pass for eligible employees.</li><li>
WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.</li></ul>
Wellness<ul><li>
Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!</li></ul>
Family<ul><li>
We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We&rsquo;ve got you covered.</li><li>
WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.</li></ul>
For policies, detailed benefits, and eligibility, please visit: https://hr.wustl.edu/benefits/<h1 class="jobSectionHeader">
EEO Statement</h1>
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity. It is the University&rsquo;s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, citizenship (where prohibited by federal law), age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.</div>

Clinical Research Study Assistant I (Hybrid) - Neurology

Search 10000+ Clinical data specialist jobs near you this March. New roles added regularly across leading industries. Apply today.