Job Details

  • Title: Clinical Trials Management Associate
  • Code: RCI-09107
  • Location: Foster City California (CA) 94404
  • Posted Date: 11/20/2020
  • Duration: 18 Months
Talk to our Recruiter

  Job Description

  • Serves as the key operational contact with external investigators and internal stakeholders
  • Has ability to evaluate a scientific proposal or protocol to identify logistical, regulatory and safety implications
  • Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements and financial or product support are processed in a timely manner and to high quality
  • Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study remains on track
  • Maintains efficient collaboration with company‚Äôs Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in timely manner
  • Acts as primary contact for study drug planning and shipping with Materials & Logistics
  • Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities
  • Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment
  • Provides monthly study updates to the appropriate internal stakeholders
  • Ensures all budget or drug supply modifications are appropriately approved, documented and tracked
  • Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management
  • In collaboration with the Clinical Program Manager (CPM), provides training for new hires, as applicable
  • Provide support and guidance, as required, to Affiliate Clin Ops & Medical Affairs personnel responsible for managing CO and ISR studies
  • Maintains a good understanding of industry standards for CO and ISR studies and keeps abreast of any new changes and developments which could impact Late Phase research operations
  • Assures site compliance with the routine protocol and regulatory requirements and quality of data
  • May resolve routine monitoring issues
  • Assists in the setting and updating of study timelines
  • Assists in CRO or vendor selection
  • With guidance from supervisor coordinates CROs or vendors
  • May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports
  • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
  • May participate in abstract presentations, oral presentations and manuscript development
  • Interfaces with individuals in other functional areas to address routine study issues
  • Organizes and leads review/approval meetings for CO proposal
  • Actively participates in Clinical Operations Quality Initiatives
  • Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories
Education/Experience:
  • Bachelor's degree in Science with relevant project management experience, or equivalent/advanced Degree in science with relevant project management experience
  • Minimum 3-5 years pharmaceutical industry experience with knowledge of drug development process
  • 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
  • Ability to understand clinical study protocols and efficient project management skills
  • Working knowledge of ICH/GCP required. Phase research experience preferred
  • Working knowledge of MS Word, PowerPoint, Outlook, and Excel
  • Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials and ability to understand clinical study protocols
  • Good understanding of financial systems and contracting process (desirable, but not required)