Clinical Data Manager
Job Description: Clinical Data Manager:
Summary: The Clinical Data Manager will be responsible for data management oversight of our CRO partners in accordance with ICH/Good Clinical Practices (GCP). Accountable for delivery of a high quality data and DM deliverables within established timelines. The Data Manager is a core member of the study team and is responsible for all data management activities from draft protocol review through study
? Ensures data management activities and deliverables for area(s) of responsibility are
completed in line with business requirements and company objectives.
? Oversees service providers to perform core data management functions, including CRF design, edit check development, user acceptance testing, data cleaning, reviewing listings,and database locking procedures.
? Review/develop data management documents, including Data Management Plans, CRF Completion Guidelines, edit check specifications, etc.
? Leads and manages DM tasks outsourced to external vendors and ensures that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory ? Act as primary Data Management contact and contributor for assigned projects; interact with other functional areas including clinical, regulatory and statistics.
? Review of SDTM datasets supplied by the vendor to ensure consistency across a program and indication; Review of Pinnacle 21 reports.
? Attends investigator meetings and gives input into the presentations that involve relevant data management topics; gives presentations.
? Participate in the development and maintenance of Standard Operation Procedures (SOPs) and Work Instructions related to data management activities.
Required Skills: Ability to work in a virtual, cross-functional team environment. • Experience with EDC including CRF design/review/approval, data review, issuing and resolving queries • Understand SDTM and ADaM reporting requirements • Strong problem-solving skills • Highly motivated and ability to work independently • High attention to detail and accuracy
BA/BS or higher in a scientific field. At least five years of data management experience in a pharmaceutical or clinical research setting. Understanding of FDA and international regulations and GCP.