Clinical Data Management - Contractor

Position Summary:

Clinical Data Management (CDM) is responsible for effective quality execution of CDM activities performed in-house or outsourced and assists in oversight of CDM vendors.

Principal Duties and Responsibilities include the following:

• 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)
• May assist in data cleaning activities for assigned 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

Qualification Requirements:

• Bachelor's degree in health profession, science, or related field
• Five to eight (5-8) 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