Senior Clinical Trials Management Associate- Late Phase
7h ago

Job Description

Specific Responsibilities and Skills for Position :

  • Must meet all requirements for Clinical Trials Management Associate (CTMA) position and must have demonstrated proficiency in all relevant areas
  • Serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs
  • Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management
  • 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
  • Assist the CTM to organize and lead review / approval meetings for CO proposal
  • Prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions
  • Able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions
  • Participate in or manage project meetings and conference calls with CROs, vendors, and multi-functional teams
  • Able to anticipate obstacles and proactively develop solutions to achieve project goals
  • Develop a general understanding of functional issues and routine project goals from an organizational perspective
  • Participate in abstract presentations, oral presentations, and manuscript development activities
  • Interact and cooperate with individuals in other functional areas to address routine study issues
  • Develop tools and processes that increase measured efficiencies of the project
  • Assist in trainings for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs),
  • For GS studies, assist in selecting Contract Research Organizations (CROs) or vendors
  • Assist with the setting and updating of study timelines
  • Participate in departmental, or interdepartmental, strategic initiatives under general supervision
  • Assist in review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
  • Conduct site evaluation, initiation, co-monitoring, and closeout visits, in addition to the routine monitoring visits
  • Ensure that the site complies with the protocol and regulatory requirements for GS studies
  • For GS studies, draft and coordinate review of protocols, informed consents, case report forms, and monitoring plans
  • Travel may be required
  • Knowledge :

  • Excellent verbal, written, interpersonal and presentation skills are required
  • Knowledge of FDA and / or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
  • Working knowledge and experience with Word, PowerPoint and Excel
  • Experience and Skills :

  • At least 3+ years of experience and a BS or BA in a relevant scientific discipline
  • At least 3+ years of experience and an RN (2 or 3 year certificate)
  • LI-MG1

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