Clinical Trial Manager/Senior Clinical Trial Manager, Clinical Operations

Full Time

San Francisco, CA

Reports to

Head of Clinical Operations

GENERAL DESCRIPTION

The Clinical Trial Manager (CTM)/Senior Clinical Trial Manager (Sr CTM) should be able to independently manage all components of a clinical trial, leading a multidisciplinary, cross-functional Study Management Team. The CTM/Sr CTM is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements.

RESPONSIBILITIES

The Clinical Trial Manager/Senior Clinical Trial Manager will be responsible for:

  • Serving as a key operational contact with external investigators and internal stakeholders, for successful implementation of studies
  • Providing critical evaluations of operational feasibility of scientific proposals and clinical protocols
  • Establishing strong cross-functional relationships and providing strong leadership skills with counterparts in other internal functional teams to ensure efficient execution of study management processes
  • Proactively identifying potential operational challenges and - in collaboration with senior team members - providing timely resolution plans to ensure study remains on track
  • Implementing and maintaining working processes to promote high quality, efficient, and compliant systems and tools for study management
  • Maintaining a good understanding of industry standards and regulations for studies and keeping abreast of any potential changes and developments impacting clinical operations
  • Drafting and coordinating the review of relevant documents including protocols, informed consents, case report forms, monitoring plans, and clinical study reports
  • Must be able to understand, interpret and explain protocol requirements to others
  • Maintaining study timelines
  • Coordinating review of data listings and preparation of interim/final clinical study reports
  • Contributing to the development of RFPs and participating in selection of CROs/vendors
  • Mentoring and developing junior clinical operations staff
  • Thorough knowledge of FDA and ICH Guidelines, and GCP governing the conduct of clinical studies
  • Creation and maintenance of high quality internal Clinical Operations databases and document repositories for ongoing and new clinical programs
  • Must be able to resolve clinical study related problems using national and international regulations, guidelines, and investigator interaction
  • Provide guidance and training to CROs, vendors, investigators and study coordinators on study requirements

PREFERRED QUALIFICATIONS:

  • Demonstrated self-starter and team player
  • Adaptable to a dynamic environment
  • Highly detail-oriented
  • Strong interpersonal and organizational skills
  • Excellent written and verbal skills
  • Experience in infectious diseases (especially hepatitis B-related) trials is preferred

MINIMUM REQUIREMENTS

  • A minimum of a Bachelor's degree is required (life science degree is preferred)
  • A minimum of 5+ years (for CTM level) or 7+ years (for Sr CTM level) of progressive experience in Clinical Operations overseeing trials and trial management
  • Thorough knowledge of clinical monitoring practices
  • In-depth knowledge of clinical operations, including interpretation and implementation of ICH/GCP guidelines
  • Broad experience in effective vendor management and selection
  • Computer skills including proficiency in the use of Microsoft Word, Excel, Project, PowerPoint, and other organization tools
  • Ability to prioritize and manage multiple tasks and tight timelines.
  • Ability to travel up to 15%

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