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Clinical Data Manager

Marlborough, MA

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Overview Responsible for managing all aspects of clinical data management activities for clinical programs which could span across start-up, ongoing, and database lock activities, including projects that have been contracted to CROs as well as internal paper or EDC projects. Responsibilities Ensure data accuracy and integrity in preparation for statistical analysis, ensuring the quality of data produced either at Oxford Immunotec (u201cOxfordu201d) or by CROs Participate in the development of database standards and ensure that when CROs perform data management activities that they adhere to these standards Review clinical database-related output and deliverables produced by CROs on an ongoing basis to ensure database quality and integrity for CRO and Oxford Data Management Develop and standardize case report form design Ensure that all clinical data received and processed are completed and accurate for all parameters required by the study protocol per Oxford Data Management SOPs Understand and maintain documentation that SOPs are followed for Oxford Immunotec Data Management Compare and reconcile adverse event data captured in Drug Safety with adverse event data captured on the case report form (as applicable) Review and evaluate any data received from sources other than case report forms (e.g., central laboratory data) and ensure readiness for analysis. Code concomitant medications, and other data as needed. Design and produce, in conjunction with Clinical and Biostatistics, data listings for review of the accuracy, completeness and consistency of clinical trial data Specify database edit checks and follow data discrepancy resolution procedures Monitor timelines and ensure that deadlines are met. Participate in development and maintenance of Standard Operation Procedure (SOPs) Oversee CROs in their delivery of data management milestones where appropriate; liaise with third party vendors and EDC vendors in a project manager capacity Maintain familiarity with relevant clinical topics and issues Regular attendance and timeliness is essential Qualifications Bachelor of Science degree preferred, preferably in health related field and/or computer; or some college and strong exprerience 3- 6 yearsu2019 experience in clinical data management in the pharmaceutical/biotechnology/diagnostic industry Experience in all phases of data management for clinical trials is preferred Diagnostic experience a big plus EDC experience preferred Demonstrated ability to follow Clinical Data Management SOPsu00a0 Coding experience with WHO Drug, ICD-9, MedDRA desirable Knowledge of GCP, regulatory and ICH Guidelines as applicable to data management Excellent written, verbal and organizational skills; work effectively as a team player PHYSICAL DEMANDS: The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

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