- Together We Win: We champion teamwork, celebrating every achievement as a shared success.
- Guided by Insight: We make data-driven decisions, using our collective experience to shape the future of our business.
- Every Day Matters: We act with urgency to bring transformative therapies to patients by being nimble, decisive, and effective.
- Driven By Excellence: We set a high bar and hold ourselves accountable to deliver exceptional results in everything we do.
- Empowered To Act: We invest in our team and value transparency, fostering trust and a sense of ownership.
- Lead the start-up, ongoing day-to-day activities, close-out and reporting of clinical studies.
- Select and manage CROs, vendors, and consultants, negotiating contracts and budgets.
- Manage study level spend and budgets and support budget planning for specific development program(s).
- Oversee performance of CROs and third-party vendors to ensure the trial is conducted in compliance with study protocol, GCP, and within scope of work; identifying areas of concern and escalating appropriately.
- Drive CRO, third party, and clinical site training on protocols and practices.
- Maintain Trial Master Files (TMFs) as stipulated in study specific plans.
- Lead site qualification and selection, study initiation visits, and oversee routine monitoring and close-out visit conduct.
- Develop and maintain good working relationship with clinical site personnel.
- Review of CRO authored monitoring visit reports and identify key performance and quality trends.
- Manage and conduct review of clinical data listings and summary tables.
- Manage Investigational Product (IP) release process to clinical sites and manages site activation process.
- Develop dashboards and status reports to communicate study status and progress internally and externally.
- Contribute to the preparation of clinical protocols and amendments, and lead the development of informed consent forms, study plans, study guidelines and work instructions, case report forms, and any other clinical research related documents.
- Track and manage biologic sample collection, shipment, and assay results reporting.
- Track and report on progress of study including site activation, subject screening and enrollment, monitoring visits.
- Bachelor's degree or equivalent combination of education/experience in science or health-related field required, PMP Certification a plus.
- At least 5 years of clinical trial implementation experience preferably in a Sponsor environment.
- Highly motivated and energetic individual seeking to grow in a small company environment.
- Working knowledge of ICH Good Clinical Practice (GCP) and the practice of clinical trial implementation.
- Knowledge of Good Pharmacovigilance Practice, Good Clinical Laboratory Practice, and/or Good Manufacturing Practice is a plus.
- Strong interpersonal skills.
- Capable of working in a fast-paced environment and taking initiative in seeking and utilizing available resources to effectively problem solve, all while ensuring the clinical trial is executed within compliance of regulations and of the highest quality.
- Proficiency in MS Office (Word, Excel, PowerPoint, Project, Outlook).
- Direct experience monitoring clinical trials or as a study coordinator is a plus.
- Up to 20% travel may be required.
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Senior Clinical Trial Manager - Palo Alto, United States - Evommune, Inc.
Description
Job Description
Job DescriptionABOUT EVOMMUNE
Evommune, Inc., a Palo Alto based biotech company, is creating game-changing science to treat immune-mediated inflammatory diseases by discovering, developing, and delivering therapies that address symptoms and halt progressive disease. For more information, visit
This hybrid position is currently expected to be in the office 2 days a week with the option of working remotely 3 days a week. Currently, most Evommune employees attend the office on Tuesdays and Wednesdays (at a minimum). The position reports to the Director of Clinical Operations.
Our Core Values
Before we dive into the specifics of the role, it's important to highlight the core values that are integral to our Evommune community. Our values are not just words; they shape our culture, guide our decision-making, and define what it means to be part of our team.
We seek individuals who resonate with these principles, as they are essential for thriving in our collaborative, innovative, and dynamic work environment.
THE POSITION
Senior Clinical Trial Manager
Evommune is seeking a highly motivated, dynamic Senior Clinical Trial Manager to support preclinical research at Evommune, reporting to the Director, Clinical Operations, responsible for operational management, oversight, and execution of one or more clinical trials including Contract Research Organizations (CROs) and third-party vendors, and consultants as needed.
Responsibilities
Qualifications
Compensation
The salary range for this position is $130,000 - $190,000 and the position may be eligible for performance-based bonuses and/or equity-linked compensation. Salary ranges are determined by role, level and location and additional factors, including job-related skills, experience, and relevant education or training. We offer Company-sponsored benefits, which include: comprehensive health, dental and vision plans, and pet insurance. In addition, we provide a 401(k) plan, ample time off programs, paid parental leave, life insurance, disability insurance and an employee referral bonus program.
Evommune is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
