Clinical Trial Manager - West Coast - Contractor - Remote

Functional Services Los Angeles, California San Diego, California San Francisco, California Valencia, California Portland, Oregon Seattle, Washington Fremont, California Los Altos, California Menlo Park, California Las Vegas, Nevada Oakland, California Palo Alto, California Redwood City, California Newark, California San Jose, California Stockton, California


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. 

We’re looking for an exceptional Clinical Trial Manager to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world. 

At Premier Research, we are science-minded and heart-centered. Join us.

As a Clinical Trial Manager, you will be: Responsible for assisting sites in the transition of patients from active clinical trial status to end-of-trial access drug programs, including open-label and commercial product. You will support assigned studies in collaboration with global study team members, by executing administrative functions such as minute taking, data entry, tracking, binder creation, and supply distribution. Also responsible for participation in study meetings, essential document review, and Trial Master File (TMF) processing. May also participate in budget negotiation, fee tracking, and amendment processing in accordance with protocol, standard operating procedures, International Organization of Standardization (ISO)/Good Clinical Practices (GCP) and other applicable regulatory requirements. Provides support in start-up, enrollment, follow-up and closure of clinical trial activities.

ROLE RESPONSIBILITIES:

  • Assists sites in transitioning patients from the clinical trial to subsequent access programs, including commercial product access
  • Participates in Clinical Research Organization/vendor selection process
  • Oversees vendor activities including reviewing monitor visit reports, participating in vendor meetings, supporting development and management of vendor oversight plans/trackers, and identifying and mitigating escalating issues or risks as appropriate
  • Manages and oversees site start-up, subject recruitment, enrollment, study management, monitoring, site management, Trial Master Files (TMFs), and data cleaning
  • Participates in the design of Case Report Forms (CRFs) and the development of project plans and clinical reports
  • Proactively identifies potential study issues/risks and recommends/implements remediation
  • Supports the management of study related activities including timelines, study visits, site selection, site initiation, site management, study drug management, closeout activities, trackers, and data sharing forums
  • Assists in the development, review and approval of regulatory documents, as well as all other required study documents, in a manner that is GCP compliant
  • Manages ongoing communication of operational issues and provides accurate progress reports on assigned activities to study team
  • Responsible for managing site and/or vendor budgets
  • Participates in and manages quality data cleaning activities, such as data listing reviews
  • Participates in and facilitates project team discussions and meetings.
  • Leads and/or participates in quality improvement and process improvement initiatives.
  • Performs additional duties as assigned

REQUIREMENTS:

  • Bachelor’s degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field, or equivalent combination of education, training and experience
  • 3 to 5 years of study management (or equivalent) experience in clinical and drug development
  • Must have experience in access drug programs
  • Proven experience in managing specialty labs and outside vendors
  • Strong leadership skills; ability to build and motivate teams to achieve results; ability to influence and inspire action through strong decision-making skills
  • Demonstrates excellent English verbal and written communication
  • Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (e.g., Outlook, Work, Excel, etc.)
  • Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
  • Strong analytical and organization skills; able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
  • Ability to be productive and handle multiple tasks to meet deadlines in a dynamic environment