Dice is the leading career destination for tech experts at every stage of their careers. Our client, S4 Analytics, is seeking the following. Apply via Dice today!
Job Details
Description
Support multiple studies either in-house or outsourced; provide CRO oversight (May operate as Lead Data Manager coordinating all Data Management tasks for the assigned studies.
Supports decision making regarding trial database and CRF designs, timelines, vendor selection, and CRO oversight.
Responsibilities
• Coordinate Database build, Design CRF, author/review Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines per agreed study timelines
• Review and provide guidance/inputs to CRO for all outsourced Data Management activities including but not limited to CRF design, Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines.
• Participate in User Acceptance Testing activities as needed.
• Liaise with Safety team or Lab vendors and perform/oversee External data reconciliation and SAE reconciliation.
• Conduct review/QC of clinical trial data; write/resolve queries and track the status of data cleanliness and perform all tasks required for database lock.
• Respond and provide trial related support to cross functional groups such as Biostatistics, Clinical Research, etc.
• Attend meetings and report on study status, metrics, timelines, etc.
• Other data management department and trial related activities as delegated
Minimum Job Requirements
• BA/BS in science related field
• 4-5 years of experience in clinical data management
• Clinical data management background with various EDC systems
• Strong Project Management skills
• Excellent, verbal, written and interpersonal communication skills
Preferred Skills & Experience
• Prior experience of working with studies across all phases or Clinical Development (Phase I – III). Specialized experience with Phase I studies or Post Marketing Surveillance studies or experience of working with Real World Data is a plus.
• Familiarity with tools such as J review, SAS and Excel and proficiency with Electronic Data Capture systems preferably with Medidata Rave. Knowledge of e-source/ePRO/eCOA data is a plus.
• Familiarity with CDASH, SDTM and medical terminology principles in relation to study design
• Good working knowledge of Google Cloud Platform.
Senior Clinical data manager
