Clinical Project Manager
Feb 20, 2023
Palo Alto (Remote)
This position is for a company who is developing a therapeutic discovery and care delivery platform for Alzheimer’s to slow or stop disease progression before cognitive symptoms develop.
The Clinical Project Manager (CPM) manages all Clinical/Study Trial team activities for assigned project(s). The CPM is accountable for successfully delivering the study team activities at the project level by meeting company and regulatory requirements according to time, quality/scope, and budget constraints.
Essential Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform the following:
Proactively manage project-level operational aspects of the Study Trial Team (STT), including management of trial timeline, resources, and vendors.
Provide efficient updates on study/trial progress to the CEO, Head of Product, and fellow leadership team regarding vendor updates, project plans, study/trial budget and timeline management, quality standards, and risk mitigation.
Lead sponsor study startup process, including but not limited to conducting the Study/Trial Kick-off meeting, the set-up of trial master file (TMF), Study/Trial Agreements, supplies, and budgets.
Ensure effective project plans are in place and operational for each study/trial. Work proactively with the study team to set priorities per applicable project plans, company standard operational procedures (SOPs), guidelines, and regulatory requirements.
Ensure potential study risks are escalated to the attention of the CEO when appropriate.
Review and approve site visit reports; ensure tracking, follow-up, and resolution of site issues have been completed promptly.
Monitor the quality of vendor deliverables, address quality issues with the appropriate team member, and identify opportunities to improve training, execution, and quality control across the team
Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner
Review and approve vendor responses to quality assurance audits for appropriateness, timeliness, and accordance with company SOPs and regulatory requirements.
Ensure all project-level study documentation is filed in the TMF following company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance, and archival procedures
Effectively provide support to the Study Site team in the conduct of the trials
Two or more years of clinical operations experience for CPM, with increasing levels of responsibility, in the Medical Device or CRO industry is required.
One or more years of clinical project management experience at a sponsor or CRO company is preferred for CPM
Therapeutic experience (preferred)
Experience in early phase trials (Phase I-II) and First-In-Man trials (preferred)
This is a high-growth, fast-paced small organization. Being productive and successful in an intense work environment is critical. Willingness and ability to travel domestically is required, it is anticipated that this will be less than 20% of work time.