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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.

Requirements:

• BA/BS in science related field.
• 4 plus years of experience in clinical data management to include overseeing CRO Data managers and performing quality checks for the project deliverables.
• Clinical data management background with various EDC systems.
• Strong Project Management skills.
• Excellent, verbal, written and interpersonal communication skills.
• 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 working with Real World Data.
• 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.
• Familiarity with CDASH, SDTM and medical terminology principles in relation to study design.
• Good working knowledge of GCP.
• Hybrid work arrangements will allow work from home combined with your presence on-site at US HQ in Florham Park, NJ.