Sr. Clinical Trial Manager

Location: San Francisco, CA

Summary

The Senior Clinical Trial Manager will independently manage all components of a clinical trial, leading a multidisciplinary cross-functional Study Management Team. The assigned clinical trial(s) may be high complexity or high-risk. The Senior Clinical Trial Manager 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 and company’s SOPs. This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities

  • Oversee and manage all aspects of a clinical trial in accordance with company’s SOPs, ICH/GCP regulations and study-specific manuals and procedures
  • Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable
  • Develop and manage effective relationships with key study stakeholders
  • Responsible for key study quality metrics (i.e. eligibility, primary endpoint, data, etc.)
  • Lead the identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with company’s SOPs
  • Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables and issue management
  • Manage the clinical study budget, ensuring the project remains within scope and out of scope activities are identified and handled appropriately
  • In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary
  • Contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms and other clinical research related documents
  • Ensure clinical data are reviewed in accordance with study date review plans and that a final, clean dataset is provided upon database lock
  • Project and coordinate study supply and packaging requirements
  • Manage expert consultant activities for study related activities, including effective communication
  • Identify program/resource gaps and proposes solutions
  • Provide weekly enrollment and program updates to senior management
  • Identify and share best practices and process improvement with colleagues to ensure optimal efficiency and consistency in Clinical Operations
  • Lead or participate in functional initiatives and/or activities as assigned
  • May mentor and develop junior clinical operations staff

Requirements

  • BA Degree or equivalent is required (live science degree is preferred)
  • Typically an average of 8-10 years in the pharmaceutical industry is required, including but not limited to 5 years’ experience independently management all aspects of multiple Clinical Pharmacology studies
  • Must have demonstrated problem solving abilities and strong organizational skills
  • Excellent written and verbal communication skills are required
  • Strong computer skills (MS Office) are required
  • Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required
  • Must be a demonstrated self-starter and team player with strong interpersonal skills
  • Must possess excellent cross-functional clinical project management skills
  • Demonstrated ability to develop and implement SOPs and Study Plans
  • Strong experience working as a Clinical Researcher Associate is preferred and thorough knowledge of clinical monitoring practices is required