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Full-Time

Senior Clinical Trial Manager

Confirmed live in the last 24 hours

Revolution Medicines

Revolution Medicines

201-500 employees

Specializes in precision oncology therapies

Biotechnology

Compensation Overview

$115k - $138kAnnually

+ Equity Awards

Senior, Expert

San Carlos, CA, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Management
Quality Assurance (QA)
Requirements
  • BS or MS degree with a minimum of 6 years clinical operations experience in the pharmaceutical or biotech industry, preferably the majority in oncology drug development
  • Hands-on experience of running early-stage clinical trials within an industry environment
  • Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials
  • Experience in selection of CROs/ vendors and management of external resources
  • A demonstrable record of strong vendor management and teamwork
  • Direct experience of managing clinical CROs
  • Excellent written and verbal communication skills
  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important
  • Ability to travel (~25%)
Responsibilities
  • Management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonization (ICH)/ GCP guidelines
  • Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., core labs, Electronic Data Capture (EDC) provider, and independent contractors) to execute clinical trials
  • Reviewing and contributing to the development of study-specific documentation including clinical trial protocols, case report forms, study guides/manuals, informed consent forms and clinical database
  • Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF)
  • Participation in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals
  • Following up on assigned team action items and identification, escalation, and resolution of issues as needed
  • Collaboration with contracts specialist to review and negotiate Clinical Trial Agreements and site specific study budgets
  • Assessment of adequacy/feasibility of potential clinical investigators and sites including evaluating facilities, personnel, patient referral base, and adherence to GCP
  • Development of clinical study monitoring priorities and Monitoring Plan in conjunction with CRO
  • Conduct site visits (e.g., training visits, site initiation visits, monitoring visits), as required
  • Managing investigational product accountability and reconciliation process
  • Assistance with the preparation of safety, interim and final clinical study reports, and resolution of data discrepancies
  • Providing clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies
  • Preparation and tracking of study participant enrollment projections vs. actuals and study budgets
  • Serving as primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies

### Welcome to Revolution Medicines, crafting the future of oncology with precision. Our focus is on advancing RAS(ON) inhibitors and RAS Companion inhibitors, marked by the remarkable journey of our lead product, RMC-4630, through its clinical phases. Supported by a team of passionate oncology experts, we are steadfast in our mission to develop treatments that precisely target oncogenic mutations, promising a brighter, healthier tomorrow for patients everywhere. ###

Company Stage

IPO

Total Funding

$1.3B

Headquarters

Redwood City, California

Founded

2014

Growth & Insights
Headcount

6 month growth

14%

1 year growth

42%

2 year growth

92%