Performs Lead CDM role for assigned studies
Designs and/or assists with design of the clinical database based on protocol and study needs, including queries and dynamics
Performs User Acceptance Testing (UAT) of the clinical database
Authors, reviews, and approves study specific CDM documentation (DMPs, CCGs, DTAs, EDC specifications)
Performs data cleaning activities for assigned studies; provide oversight of data cleaning activities for outsources studies
Monitors study progress to ensure successful achievement of study milestones
Provides oversight of CDM vendors for assigned studies
Ensures that all CDM operations are conducted according to applicable SOPs
Identifies and communicates potential risks/challenges to head of CDM and study CPM based on protocol, timelines, forecasts, and study metrics.
Collaborates with the study team to identify, develop, and implement risk-based solutions
Ensures CDM study documents are filed in the TMF (Trial Master File) in a timely manner
May oversee tasks delegated to other CDM staff for assigned studies
Performs other duties as required

Requirements

Bachelor’s degree in health profession, science, or related field
Six to eight (6-8) years of CDM experience. Minimum 3 years of Lead CDM experience
Knowledge of SOPs, GCP (Good Clinical Practice) standards, and CDM systems
Experience with multiple EDC systems
Experience with other CDM systems such as analytics desired
Advanced MS Excel skills (formulas, pivot tables); basic SAS or other programming is a bonus
Computer literacy, proficiency in MS Office suite, TEAMS, SharePoint etc
Excellent written and oral communication skills
Excellent organizational skills and attention to detail
Ability to prioritize and multitask

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical database designUser Acceptance Testing (UAT)data cleaningCDM documentationEDC systemsanalytics systemsMS ExcelSAScomputer literacyMS Office

Soft Skills

communication skillsorganizational skillsattention to detailprioritizationmultitasking