ClinDatrix, Inc. is seeking a full time Data Management Project Manager. Ideal candidate should be located in Southern CA, available to work in the ClinDatrix office, and have experience managing large, complex clinical studies.
ClinDatrix is a full service CRO located in Irvine, CA, servicing the biotechnology, medical device, and pharmaceutical industries. ClinDatrix is dedicated to clinical research, data management, medical safety, and statistical analyses and reporting.
Responsibilities
• Responsible to plan, coordinate and manage the day-to-day data management operations that meet the goals and objectives of the Sponsor while adhering to all ethical, medical, regulatory, and ClinDatrix requirements.
• Monitor and ensure compliance to study timelines and budgets.
• Act as the primary data management liaison with the Sponsor and regularly communicate with the project team (both internal and external to ClinDatrix) and the Sponsor to provide updates on the progress of the clinical trial.
• Liaise with the Clinical Department to review discrepancies and ensure that queries are appropriately answered by the clinical sites in a timely manner.
• Responsible for the review and approval of all study-related documentation (e.g., Data Management Plan, Edit Specifications, Data Entry Guidelines, etc.) throughout the project to ensure that SOPs and sponsor guidelines are followed in an appropriate and consistent manner.
• Develop and maintain appropriate academic knowledge and practical experience necessary to conduct the job in a professional and competent manner, and become familiar with current knowledge, practice, and capabilities in relevant fields of science/medicine and in federal regulations.
• Review and approve project time reporting of staff working on assigned projects.
• Direct Data Management staff to ensure all study activities are performed in a professional manner, and in accordance with the protocol and applicable regulations, e.g., GCP and SOPs.
• Provide leadership and development support to the Data Management team.Qualifications and Requirements
• Bachelor’s degree or above with at least 5 years of data management experience in the clinical research or pharmaceutical industry.
• Knowledge of Good Clinical Practices (GCP), clinical trials management, site monitoring, regulatory compliance, and clinical data management.
• Excellent written and verbal communication skills and strong interpersonal skills in order to interface with physicians, sponsor representatives, consultants, team members and various audiences.
• Strong organizational skills with ability to multitask and plan activities as it relates to management of clinical trials.
• Financial management skills as applicable to overseeing project expenditures and forecasts.
• Ability to problem solve, build teams, and to lead and motivate others.
• Advanced computer skills (Word, Excel, PowerPoint).
• Effectively work independently as well as within a team matrix.
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