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PThe CTMS and Reporting Manager leads the successful delivery of Clinical Trial Management System (CTMS) database administration, report generation, basic trending and analysis. The primary goal of the CTMS and Reporting Manager is to ensure members of Clinical, Scientific & Medical Affairs (CSMA) receive value from CTMS solution, retain and expand customer use of the solution and help build out and institutionalize best practice tools and templates with the solution. This position will coordinate with Global Biostatistics, Global Data Management, and Clinical Project Management to ensure KPIs and reports generated from CTMS are accurate and in accordance with policies.
Responsibilities: (Please specify % amount against each responsibility)
Manage system configuration, system integration, training, change management and communications in order to achieve operational objectives. (40%)
Provides ongoing support and assistance to CSMA project teams on data export, standardization, and reporting requests. (20%)
Analyze KPIs and key business drivers, patterns and trends and present to appropriate CSMA project teams along with recommendations / action plans for improvement. (10%)
Interacts with Quality Assurance, IT Business Partners and CTMS vendor to ensure proactive and successful implementation of system upgrades following all applicable SOPs and regulations allowing system to be always audit ready. (15%)
Provide support to management with regard to the implementation of the CTMS across business partners, such as Clinical Research Organizations. (15%)
Location: Memphis, US or Andover, US
Education: Bachelor of Science degree
Licenses/ Certifications: none
Experience: 5 - 7 years of relevant reporting and analytics experience in a Pharmaceutical, Biotech, Medical Device, CRO or related industry. Prior Edge CTMS administration/reporting super user experience is preferred, but not required.
Competences: (1) Experience in CTMS systems, reporting and analytic tools (2) Record of excellent performance in a similar role and process the knowledge and technical skills to be successful (3) Highly self-motivated and self-directed (4) Professional communication skills with strong oral and written English (5) Ability to interact with and manage vendors (6) Knowledge and interpretation of US Code of Federal Regulations, ISO 14155, ICH GCP (7) Knowledge of Clinical Trial Management and Clinical Research Associate roles (7) Ability to work in a matrix environment and values the importance of teamwork (8) Lead others in the development of problem solving (9) Ability to manage multiple projects simultaneously or projects with multiple workstreams (10) Strong competence in the use of Power Point and Microsoft Excel.
Physical Demands: Sitting most of the day; light lifting.
Travel Requirements: up to 25%
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About LanceSoft Inc
Lancesoft is one of fastest growing and largest clinical staffing firm in the U.S. and an employer-of-choice for over 1000+ consultants - this may be your opportunity to join us!
We recruit top-notch talent for Healthcare, Pharmaceutical, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking/ Finance, Manufacturing, Automobile, Media, Transportation, and Government clients coast-to-coast across the US, Canada and India. We are one of the fastest-growing companies in the industry and
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