Assists in the planning, execution and reconciliation of clinical projects, while adhering to budget, scope and schedule requirements. Coordinates clinical budget and related pricing strategy services for the purpose of executing a clinical trial or ancillary services agreements, including medical education and communication programs. Utilizes and implements cost models to support pricing, and helps to develop and maintain resource modeling within research and development.
Responsible for the planning and execution (process planning) across different medical affairs activities, that can include educational and training programs, clinical study planning, and internal and external medical and scientific communication campaigns. Coordinates the activities of functional groups that comprise the larger collaborative medical affairs project teams including, but not limited to the pathology office, clinical operations and biometrics, lifecycle commercial teams, affiliate medical and commercial teams, regulatory, compliance, contracting and legal, and various launch and on-market support teams . Applies best practices in the development, initiation, planning, execution, control and closing of projects. May also interact with finance, research and development, marketing, manufacturing and other departments as appropriate.
The Project (Clinical) Manger may also support database management, in collaboration with the Senior Medical Information Specialist in support of corporate IVDR directives and management and in support of regulatory and notified body submissions.
– Expert knowledge and application of scientific principles and concepts.
– Demonstrated proficiency in typing, use of Adobe Acrobat 9 Pro, Microsoft Office products including Microsoft WORD, Outlook, and Power Point and the Google suite of products.
Experience with EndNote and Microsoft Visio 2010 preferred.
– Excellent and proven leadership skills, team skills, written and oral communication skills.
– Strong ability to handle multiple projects simultaneously.
– Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
– Advanced technical or clinical writing skills.
– Ability to produce reports and documents independently and evaluate those of others.
– Demonstrated creativity and ingenuity through the development of novel, multi-disciplinary approaches to projects and strategic issues.
– Skill and ability in implementing strategic projects, acting as a catalyst to remove organizational barriers, reduce cycle times and direct process improvements.
– Ability to rapidly develop expertise in FDA guidelines for in vitro diagnostic devices and the statistical basis for sensitivity, specificity and reproducibility testing required for validation and FDA clearance and approval.
– Ability to rapidly develop expertise in the company’s internal document management system.
Manager's Must Haves: 1) Sound logic and reasoning. 2) Solid understanding of the scientific method and be able to critically think through unforeseen opportunities. 3) Ability to communicate and write clearly and concisely. 4) Proficient Keyboarding. 5) Interacts well with others. 6) Capable of working independently.
– Bachelor of Science, with a strong science background preferred.
– Two years of experience in project management, critical data analysis, and report generation in a clinical or regulated environment
– Experience in study design and data analysis.
– Experience in regulatory, academic or clinical writing is preferred.
– Experience in design control processes is preferred.
– Experience with approval of in vitro diagnostic devices is preferred.
– Oncology experience is preferred.
Source: Job Diva – Job Listing