Sr. CTMA, Late Phase Clinical Operations - CA in Foster City, CA at Apex Life Sciences

Date Posted: 6/3/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    6/3/2018
  • Job ID:
    846204

Job Description


Sr. CTMA - Late Phase Clinical Operations 
support HCV (CHIME) 


Non-Sponsored studies: 

  • Sr. CTMA -Late Phase plays vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects: 
    • 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’s 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. 
    • 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. 
    • Performs administrative duties in a timely manner as assigned. 

May contribute to sponsored studies: 

  • With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required. 
  • 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. 
  • May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants. 
  • Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives. 
  • Travel is required. 

Skills/Experience requirements: 

  • Skills required demonstrating key core values of Integrity, Teamwork, Excellence, and Accountability 
  • Strong analytical, conceptual and business judgment skills. 
  • Excellent planning, organizational and administrative skills. 
  • 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 with best practices in the industry
  • Effective 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. 
  • Good understanding of financial systems and contracting process (desirable, but not required). 
  • 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 

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.