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Clinical Trials Management Associate - II

Company: Unicon Pharma
Location: San Jose
Posted on: October 18, 2020

Job Description:

Location: Foster City, CA 94404 Duration: 12 Months-Contract. Description: This position is focused on company sponsored studies: Coordinating and supervising all aspects of a clinical study. Monitors clinical trial sites. Assists Clinical Program Manager in overall study management. Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports. Maintains study timelines. Contributes to development of study budget. Contributes to development of RFPs and participate in selection of CROs/vendors. Manage CROs/vendors. Coordinates review of data listings and preparation of interim/final clinical study reports. May contribute to development of abstracts, presentations, and manuscripts. Ensures effectiveness of site budget/contract process. Participates in meetings and conference calls with CROs, vendors, and multi-functional teams. May be asked to train CROs, vendors, investigators, and study coordinators on study requirements. Assists in determining the activities to support a project's priorities within functional area. Under supervision, may design scientific communications within the company. Skills/Experience requirements: Skills required demonstrating key core values of Integrity, Teamwork, Excellence, and Accountability Strong analytical, conceptual and business judgment skills. Excellent planning and organizational and administrative skills to demonstrate initiative. Demonstrate core values of strong team work and accountability with ability to prioritize competing timelines and deliver excellent results while working independently Significant technical expertise and learning ability with demonstrated flexibility required to maintain pace in the market. Exceptional communication skills both oral and written. Excellent problem solving ability. Effective project and time management skills. Tenacity and perseverance to ensure high level customer service. Teamwork is a mandatory requirement as it involves building and maintaining internal/external networking and cross-functional collaboration. High sense of urgency and commitment to excellence in the successful achievement of objectives and program execution. Ability to demonstrate good business judgment. Good understanding of financial systems: good understanding of contacting process (desirable, but not required). Education/Experience: Bachelor's degree in Science with relevant project management, or equivalent/advanced Degree in science with relevant project management experience. Minimum 5-8 years pharmaceutical industry experience with strong knowledge of drug development process, required. Ability to understand and write clinical study protocols and efficient project management skills required. Phase IV studies experience preferred. Working knowledge of FDA/EMEA Regulations and ICH/GCP Guidelines governing the conduct of routine clinical trials. Working knowledge of MS Word, PowerPoint, Outlook, and Excel. Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures. Ability to develop tools and processes that increase measured efficiencies of the project. Must be able to anticipate obstacles and proactively develop solutions to achieve project goals. Must have a general understanding of functional issues and routine project goals from an organizational perspective. Preference with speaking Korean and/or Japanese.

Keywords: Unicon Pharma, San Jose , Clinical Trials Management Associate - II, Executive , San Jose, California

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