Sr Clinical Data Management Analyst

Roth Staffing is looking for a Sr Clinical Data Management Analyst.

The primary responsibility of the Clinical Data clinical data analyst is to support CDM study start up activities, including developing database specifications, authoring and executing test scripts, and preparing key CDM deliverables.

Key Responsibilities:
* Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
* Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), CRF completion guidelines, training materials and user aids in compliance with regulations.
* Perform Site/User Administration including generating and validating EDC reports and Subject PDFs.
* Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution
* Assist in leading project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
* Participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.
Skills:
* Experience with Medidata EDC (Electronic Data Capture) systems required. Experience with InForm EDC system preferred.
* Good computer skills in Microsoft Office Suite
* Good written and verbal communication skills and interpersonal relationship skills
* Good problem-solving and critical thinking skills

Education and Experience:
* Bachelor's Degree or equivalent
* 5-7 years of experience required
* Experience with CDM study startup activities will be prioritized. Medidata experience is required.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.