Minimum of 10+ years of clinical data management experience in the life science industry.
Bachelor's degree is required, with sponsor experience preferred.
5+ years of recent experience with Medidata RAVE.
Strong communication skills and ability to work in a cross-functional team environment.
Requirements:
Act as the Study Lead CDM for up to two Phase II studies.
Manage DM activities, develop/design CRFs, and conduct full UAT.
Ensure data accuracy and consistency by collaborating with cross-functional clinical teams.
Lock study databases according to criteria and timelines, working with vendors and study teams.
Job description
Responsibilities:
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.
