Manager, Clinical Data Management

Position Summary:

The Manager, Clinical Data Management (CDM), is responsible for effective execution of CDM activities performed in-house or outsourced. Provides oversight of CDM vendors and ensures data management activities meets Ocular quality standards.

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)

* 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

Qualification 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

This position will be fully remote. The ability to travel less than 5% would be desirable, but not required.