Clinical Data Deviation Analyst
Remote - US
Celerion
Celerion is committed to implementing innovative strategies with applied translational medicine to gain insights on early drug development decisions. We provide vital expertise and experience in a large clinical capacity to ensure our clients...
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.
The Clinical Data Deviation Analysis will support our need for integrity and accuracy of data collected during clinical trials in the Celerion clinics through the reporting of non-compliance to Celerion’s SOPs and protocol requirements. They will monitor and verify deviation reporting from the conduct team, ensuring entry and consistency in reporting. They will support compliance initiatives and assist research for quality event investigations as requested.
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.
The Clinical Data Deviation Analysis will support our need for integrity and accuracy of data collected during clinical trials in the Celerion clinics through the reporting of non-compliance to Celerion’s SOPs and protocol requirements. They will monitor and verify deviation reporting from the conduct team, ensuring entry and consistency in reporting. They will support compliance initiatives and assist research for quality event investigations as requested.
Essential Functions
- Data Monitoring and Verification: Daily review of IDNTs, programmable edit checks, and data queries for identification, entry, and reporting as observations, quality deviations, or protocol deviations.
- Identification of protocol and Sponsor variances to Celerion standard processes and ranges.
- Support protocol review to prevent deviations.
- Assist with the review and approval of study specific spreadsheets on behalf of the CSM.
- Contribute to the development of a plan to mitigate any risks and/or reporting requirements via attendance a study award meeting to support the team in identifying potential risks and variances to standard processes.
- Identify, request, and review programmable deviations.
- Support the creation/preparation of materials for the protocol deviation review meeting occurring at database lock.
- Ensure that all protocol deviations are completed and Veeva is locked for future updates, following the completion of the COV.
- Provide training and support to new clinical staff on questions around protocol deviations and handling.
- Support research and requests for information to assist in Quality Events.
- Recommend corrective actions for study trends when possible or known.
- Support compliance with Regulatory and SOP within Celerion through identification, education, and tracking.
- Creation, testing, and support of eCOA survey development and study schedule set up.
- Assistance with eCOA where requested.
Knowledge, Skills, Education, Licenses
- Minimum of 6 months study management or equivalent clinical experience
- Proven organization skills and ability to prioritize
- Ability to manage multiple priorities
- Excellent oral and written communication skills
- Ability to work without close supervision
- Ability to work hours required which might vary from week to week
- Strong customer service skills
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.
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Job stats:
8
3
0
Category:
Analyst Jobs
Perks/benefits: Team events
Regions:
Remote/Anywhere
North America
Country:
United States
More jobs like this
Explore more career opportunities
Find even more open roles below ordered by popularity of job title or skills/products/technologies used.
Sr. Data Engineer jobsBusiness Intelligence Developer jobsPrincipal Data Engineer jobsBI Developer jobsStaff Data Scientist jobsStaff Machine Learning Engineer jobsPrincipal Software Engineer jobsJunior Data Analyst jobsData Science Intern jobsDevOps Engineer jobsData Science Manager jobsSoftware Engineer II jobsData Manager jobsLead Data Analyst jobsData Analyst Intern jobsStaff Software Engineer jobsAccount Executive jobsBusiness Data Analyst jobsAI/ML Engineer jobsSr. Data Scientist jobsData Specialist jobsData Governance Analyst jobsSenior Backend Engineer jobsData Engineer III jobsBusiness Intelligence Analyst jobs
Consulting jobsMLOps jobsAirflow jobsOpen Source jobsEconomics jobsLinux jobsKPIs jobsKafka jobsTerraform jobsGitHub jobsJavaScript jobsRDBMS jobsPostgreSQL jobsData Warehousing jobsClassification jobsNoSQL jobsStreaming jobsScikit-learn jobsBanking jobsComputer Vision jobsPrompt engineering jobsRAG jobsPhysics jobsGoogle Cloud jobsOracle jobs
Pandas jobsdbt jobsHadoop jobsScala jobsBigQuery jobsGPT jobsR&D jobsData warehouse jobsReact jobsLangChain jobsScrum jobsDistributed Systems jobsPySpark jobsLooker jobsMicroservices jobsIndustrial jobsELT jobsCX jobsSAS jobsJira jobsOpenAI jobsRedshift jobsModel training jobsRobotics jobsTypeScript jobs