Lead Clinical Data Manager

Job Title

Act as the Study Lead CDM for up to two, Phase II studies

Manage DM activities for all assigned studies, develop/design CRFs, and full UAT

Responsible for initiation and management of study activities and documentation

Responsible for review of DM study plans including DMP, Data Validation Plans, etc.

Work closely with cross-functional clinical teams to ensure data accuracy, reliability and consistency

Ensure study databases are locked per the criteria and timelines by working together with the vendors and study teams

Other Data Management related duties as needed

Demonstrated expertise managing and executing full study start-up through close out DM activities and all data management related documentation (SOPs etc)

Experience conducting User Acceptance Training in Medidata Rave, performing edit check specifications, etc. is a must

Experience in CRO and vendor management

Experience with multiple phases of clinical development

Development of treatments for rare and serious diseases

Working as a Data Management Study Lead, responsible for managing two concurrent Phase II clinical studies within one of the client's drug programs

Requirements

Minimum of 10+ years of clinical data management experience in the life science industry and bachelor's degree (Sponsor experience is preferable)

5+ years of experience with Medidata RAVE (recent)

At least 4-5+ years of strong experience as a Lead Clinical Data Manager responsible for multiple clinical studies at one time

Excellent communication skills and ability to work in a cross-functional team environment

A strong degree of willingness and ability to wear multiple hats, work very hands-on and collaborate closely with the team is required.