Support the design, specifications, and development of eCRFs
Support the design and testing of technical CDM components including edit checks, reports, and listings
Develop Data Management Plan documents
Perform comprehensive review of data generated from the clinical study including third party/external data, SAE data and local lab data, as applicable
Manage effective communication of data issues and discrepancies to study sites via the query management process
Provide reports, status updates, feedback, and advice to key study stakeholders on the progress of data cleaning and risk identification / mitigation activities
Ensure CDM activities are performed in compliance with Good Clinical Practice, ICH Guidelines, Kyverna SOPs, regulatory guidelines, and study specific plans.
Support the filing of eTMF documentation to ensure that an inspection ready environment is maintained throughout the study lifecycle
Communicates effectively across functions to ensure that all issues are resolved according to guidelines and requirements. Escalates relevant issues to clinical study management team to facilitate timely resolution. Investigates and analyzes possible solutions

Requirements

Bachelor’s degree in life sciences, health informatics, or related field
8+ years of Clinical Data Management experience in a CRO / Pharma setting
Proficiency with clinical data systems (e.g., Medidata Rave, Oracle Clinical), and use of Data Review tools
Proficient in data cleaning and query resolution techniques
High attention to detail including proven ability to manage multiple, competing priorities, and ability to work under pressure
Excellent written and oral communication skills
In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
Understanding of CDISC standards, clinical trial design, and regulatory requirements
Operational expertise in the strategic planning and delivery of CDM deliverables at study and / or program level.
Experience in management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned studies and programs

Benefits

bonus
benefits
participation in Company’s stock option plan

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Clinical Data ManagementData Management PlanData CleaningQuery ResolutionCDISC StandardsClinical Trial DesignRegulatory RequirementsBiometricsQuality ManagementData Review Tools

Soft Skills

Attention to DetailCommunication SkillsProblem SolvingTime ManagementStakeholder ManagementTeam CollaborationAnalytical SkillsAdaptabilityLeadershipConflict Resolution