Senior Clinical Data Manager
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Employment Type: Full Time or Contract
Experience: 4 years or more
Full-Time Salary Range: $75,000 to $95,000
Consulting Rate (6-month, renewable): $70 to $90 per hour
Job Description: Provide timely and professional ongoing management of clinical trial data, Phases I to IV, by preparing validation plans and chairing validation meetings. Prepare material for and presenting at Investigator Meetings, identifying errors and inconsistencies in CRF data and ensure their resolution. Performing Serious Adverse event and external data reconciliation (e.g., laboratory data) in order that databases can be declared clean and locked according to strict quality standards. Represent Data Management in International Clinical Team Meetings; to define project level data management strategy and manage clinical trials or clinical projects.
Responsibilities: Support and assist CDA and CDMs working on trials. Provide status reports, as requested, on the progress of trial. Represent Data Management at the International and Local Clinical Trial Team Meetings. Protocol review, specifically related to the data management section, visit schema and study design. Preparation of the eCase Report Forms (eCRFs) and write eCRF Completion Guidelines. Responsible for the Validation and Planning of the clinical trial, which includes: chairing the validation meetings, writing study specific validation checks and editing standard validation checks if required. Coordination between several line function is required. Identify data review, tracking and cleaning reports required and write the necessary report specifications if needed. Perform User Acceptance Testing of the electronic database to ensure all requirements are met prior to release. Perform training on the electronic database to sites and personnel at the Investigator meeting for trials across all TAs. Also present the unique study specific eCRFs to the Investigative sites at the meeting. Travel is required as needed. Identify error/inconsistencies in the data and initiate timely resolution, directly with the Investigational site or via obvious correction. Review and close queries that have been answered by the sites. Ensure good communication between the internal and external customers. Freeze and lock data as appropriate in time for statistical review or database lock and organize interim quality data reviews. Provide support to any trial as needed. Ensure obstacles to attain trial/project objectives are communicated well in advance of becoming a reason to fail an objective. Ensure high quality and timely DBL's. Manage multiple projects or trials.
Minimum Requirements: Degree in life science, nursing or equivalent relevant experience. Typically 5 or more years experience in drug development, with at least 4 years in the discipline of data management. Work across trials, projects and TAs if required to ensure department deliverables are met. Prefer experience in leading a project team. Favored behaviors include: flexibility, positive attitude and the ability to work under pressure and meet deadlines.