Lead Clinical Data Manager

• 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.

Requirement:

• 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.