Clinical Trials Management Associate - II in Foster City, CA at Apex Life Sciences

Date Posted: 5/21/2018

Job Snapshot

  • Employee Type:
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

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’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.
•    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.

•    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.

Please email: for consideration.