Global Clinical Trial Manager (Remote)

GLOBAL CLINICAL TRIAL MANAGER (REMOTE)BRISBANE, CA Project Description: The Senior Clinical Trial Manager role (Sr. CTM) is a developing leadership role integral to driving project success within the Clinical Operations function. This position is an in-house role focused on independently managing and overseeing clinical trial sites and clinical trial activities. As a member of the cross functional study team, the Sr. CTM directly manages site performance in line with study level plans. The position is also responsible for reviewing site visit reports, vendor management and partnering with Contract Research Organizations (CRO). Essential Duties and Responsibilities:

• Scope of studies
  • One or more, increased complexity of study and number of vendors.
• Study level planning and oversight
  • Manage all day-to-day operations.
  • Monitor & site oversight by trip report review, identifying trends, gaps, on-going actions, deviations, etc.
  • Feasibility recommends US sites & countries.
  • Develops monitor training.
  • Manage drug supply.
  • Conduct clinical data review.
  • Oversee tracking of clinical samples.
  • Responsible for planning and presenting at Investigator Meetings.
  • Ensure local and global healthcare compliance policies are followed.
  • Assess risk and develop mitigation strategies with minimal oversight.
• Vendor oversight
  • Participate in vendor selection, oversee complex vendors and some aspects of CRO, review invoices prior to study lead approval.
  • Understands all vendors needed for trial, can support aspects of more complex vendors.
• Site management
  • Oversee monitoring activities, perform oversight monitor per plans, create and implement training for monitors.
  • Oversee site payments.
  • Assess KPIs, generate reports and proposes risk mitigation as needed.
  • Responsible for management of lab samples.
  • Participate in data review and query resolution.
  • Builds strong rapport and relationships with site staff and Investigators.
• Relationship and stakeholder management
  • Developed communicator, builds & maintains strong relationships internally and externally.
• Clinical documents
  • Review and approve global templates & site level documents for IRB/regulatory submission.
• Negotiating and influencing
  • Listens, seeks common ground and establishes credibility.
• Coaching and mentoring
  • Provides guidance and coaching as need to new Clinical Trial Manager and Clinical Trial Associate role.
• Business and therapeutic knowledge
  • Solid understanding of Clinical Operations, study phases and types.
  • Understands the protocol, science/biology, e.g., cardiology, mechanism of action of drug.
• Inspection readiness
  • Responsible for timely submission of documents to Trial Master File, periodic reviews of TMF for quality.
• Ability to travel.
  • Up to 25%.

• Bachelor's degree, preferably in areas such as biological sciences, health care management or life sciences research.

• Ideal candidate has at least 2-3 years of prior relevant industry experience (Clinical Trial Associate or field monitor) or experience in a clinical setting such as RN or related role.
• Highly proficient in software applications such as Word, Excel, and PowerPoint.
• Good written and verbal communication skills and proven ability to multitask.
• Efficient time management and organizational skills. Attention to detail and accuracy in work.
• Has a basic understanding of the drug development process and knowledge of FDA regulations and guidelines.

• Organizes and prioritizes numerous tasks and completes them under time constraints.
• Applies technical standards, principles, theories, concepts and techniques.
• Demonstrated success in problem solving.
• Applies strong analytical and business communication skills.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Ability to constructively interact directly with clinical site personnel.
• Develops relationships with senior internal and external personnel in area of expertise.

• Work is on projects that are complex due to high number of vendors requiring close oversight and management.
• Performs job duties with minimal guidance from supervisor.
• Works in dynamic environment across cultures, community and academic settings.

• Patients first.
• Passion for science.
• Succeed together.
• Imagine and innovate.
• Lifelong learning.