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Job #02536

About our client Our client is a company dealing in the biopharmaceutical sector, developing novel gene-based therapeutic drugs and vaccines. These products help in the production of proteins directly at the site of disease by the genes it delivers. All gene-based therapies use the same patent protected technology. Position Location Clinical Data Program Manager Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Direct the design, documentation, testing and implementation of clinical data collection and clinical database review 2) Manage and approve final databases/datasets used for various clinical documents (e.g., study reports, annual reports) 3) Manage database/datasets control and short and long-term filing/archiving 4) Coordinate and collaborate with others to design and implement clinical protocols and data collection systems 5) Develop systems for organizing the data to analyze, identify and report data and trends 6) Manage data-management issues by reviewing protocols for cross-project consistency 7) Identifying standard Case Report Form (CRF) modules to meet objectives 8) Develop and oversee data quality (QA/QC) plans and their implementation 9) Provide early strategic input into protocol design focused on data management issues 10) Review and resolve data discrepancies for standardized data validation systems and procedures 11) Develop and administer budgets, schedules and performance requirements 12) Oversee data management projects that have been contracted with CROs, as well as internal projects 13) Verify data management deliverables from vendors meet acceptance criteria 14) Resolve problems of diverse scope in which analysis of clinical data requires evaluation of identifiable factors 15) Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions Requirements 1) Bachelor’s (BA/BS) or Master’s degree in a scientific discipline or equivalent 2) 3-5 years of experience in managing clinical data projects at sponsor or CRO 3) 2-3 years of experience in managing a CRO contracted for data management activities preferred 4) Project management experience related to data management 5) Experience in managing multiple clinical data for studies in pre-approval phases 6) Demonstrated knowledge of industry standards in managing multiple clinical data for studies in the pre-approval phases 7) Superb knowledge of clinical database structure preferred 8) Ability to anticipate data management needs of clinical studies and plan for their success