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At NeuroPace, employees are our greatest asset. We are continually searching for solution-oriented individuals who can bring energy and creativity to our growing workforce. At NeuroPace, our success depends upon our ability to recruit and retain the most talented, enthusiastic and dedicated people we can find and providing them with a dynamic and challenging environment in which to thrive.

NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.

NEUROPACE, INC. IS AN EQUAL OPPORTUNITY EMPLOYER AND DOES NOT DISCRIMINATE ON THE BASIS OF RACE, COLOR, RELIGION, GENDER, SEXUAL ORIENTATION, NATIONAL ORIGIN, MARITAL STATUS, PHYSICAL OR MENTAL DISABILITY, MEDICAL CONDITION OR AGE.

Senior Clinical Trial Manager

Mountain View, CA   ·   Fulltime

Job Description

The Senior Clinical Trial Manager will report to the Director of Clinical Affairs and Data Management. The principal function of the position is to manage the execution of a portfolio of multicenter investigational device exemption clinical trials. In particular, the role assumes complete responsibility for clinical study planning, development, and launch as well as the execution of day to day study and data management activities. Success in this role is tied to establishing strong internal and external relationships, ensuring the highest integrity of the data collected, and for each study to achieve its intended goals on time and within budget while ensuring transparency and communication across the team and organization.

Responsibilities

Study Development and Leadership

• Support the development of clinical study protocols and related regulatory submissions
• Develop and manage study budgets and timelines, including personnel resource estimates
• Manage operational aspects of multiple clinical trials, with competing deadlines, from study start-up through database lock in compliance with ICH/GCP, company SOP, and other regulatory requirements as relevant to the study
• Proactively manage multifunctional clinical study teams to a identify and manage critical path activities, and achieve deliverables within the larger context of corporate goals
• Ensure that team members are appropriately trained on study conduct and company procedures
• Assist in the development of internal SOPs and processes to ensure ongoing study compliance
• Maintain inspection readiness and participate in FDA or other regulatory authority inspections
• Manage study-related vendors, including review of and input on vendor contracts, SOWs, proactive management of issues, and assistance with invoice reconciliation
• Liaise between corporate finance/legal counsel and investigator institution and vendor representatives relative to the establishment of and adherence to contractual agreements
• Establish and maintain strong working relationships with internal and external teams
• Provide frequent study updates to internal teams, including senior management, and external partners

Documentation and Data

• Develop and implement clinical study processes to support study and data management operations
• Ensure development and implementation of applicable study plans (i.e., clinical trial monitoring plan), protocols, amendments, informed consent templates, CRF forms/completion guidelines and site reference guidelines/instructions
• Manage EDC database specifications, eCRF design, clinical database validation, eCRF completion guidelines, and data management and review plans to ensure high data quality and compliance with applicable industry regulations and standards
• Review protocol deviations and data listings to ensure sponsor oversight
• Manage data query, review, cleaning process to minimize data inconsistencies, errors, or omissions
• Work with data management, statisticians and research scientists to optimize the workflow for study endpoint and adhoc dataset creation and data analysis
• Work with data management to ensure timely database locks for all assigned projects

Requirements

• BS in health sciences or related field with 7+ years relevant industry experience
• 2+ years’ experience managing project team members in a clinical research environment, preferably in the area of medical devices
• Working knowledge of GCP and regulatory compliance guidelines for clinical trials and quality assurance procedures
• Working knowledge of the FDA submission process, preferably for IDE and PMA submissions
• Keen understanding of clinical trial monitoring and data management requirements
• Experience in finance management (budget forecasting, change order management, etc.)
• Demonstrated skills in negotiation, multi-tasking, organization, and problem solving and the ability to work collaboratively and flexibly in a fast-paced environment
• Strong written communication and presentation skills including the use of appropriate medical and scientific terminology
• Experience and confidence in communicating across a diverse group of internal and external team members, including physicians, IRB staff, FDA staff, regulatory affairs, and senior management
• Willingness and ability to occasionally travel

Technical Skills

Required

• Proficiency in the use of computer applications such as MS Word, Excel, PowerPoint
• Experience working with EDC, CTMS, and eTMF systems, including system validation efforts
• Exposure or hands on experience with MedDRA and WHODrug coding
• Understating of basic statistical methods

Desired

• Experience with enterprise or customer relationship management solutions
• Experience with SQL coding
• Awareness of FDA medical device reporting requirements

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