Clinical Trials Management Associate - II
Company: Unicon Pharma
Location: San Mateo
Posted on: January 15, 2022
Location: Foster City, CA 94404
Duration: 12 Months-Contract.
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
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 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 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
Teamwork is a mandatory requirement as it involves building and
maintaining internal/external networking and cross-functional
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).
Bachelor's degree in Science with relevant project management, or
equivalent/advanced Degree in science with relevant project
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
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
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 Mateo , Clinical Trials Management Associate - II, Executive , San Mateo, California
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