Clinical Trial Management Associate - Clinical Operations
at Revolution Medicines
Redwood City, CA 94063, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 18 Jan, 2025 | USD 95000 Annual | 19 Oct, 2024 | N/A | Teamwork,Drug Development,Vendor Management,Communication Skills,Smartsheet,Protection,Email,Clinical Trials,Security,Training,Color | No | No |
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Description:
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
REQUIRED EXPERIENCE AND SKILLS:
Direct experience of running early-stage clinical trials within an industry environment.
Experience of clinical trial operations outside the USA is desirable, but not essential.
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.
Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
Excellent written and verbal communication skills.
Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.
Ability to travel (~25%).
PREFERRED SKILLS, EXPERIENCE AND EDUCATION:
BS or MS degree with a minimum of 3 years clinical operations experience in the pharmaceutical or biotech industry, preferably the majority in oncology drug development
Oncology experience, early and/or late stage
Knowledge with MS Suite, Smartsheet
Understanding of EMEA/APAC region(s) clinical trial operations.
The base salary range for this full-time position is $95,000 to $110,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
LI-Hybrid #LI-DN
Responsibilities:
Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives.
May assist in the selection, coordination, and management of CROs or vendor relations.
Partners with Clinical Program Manager (CPM) in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports.
Interfaces with individuals in other functional areas to address routine study issues.
Reviewing monitoring reports and other study documentation as required.
Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).
Following up on assigned team action items and identification, escalation, and resolution of issues as needed.
Assessment of adequacy/feasibility of potential clinical investigators and sites including evaluating facilities, personnel, patient referral base, and adherence to GCP.
Managing investigational product accountability and reconciliation process Assists in the review of routine data surveillance, coordination of the review of data listings and preparation of interim and final clinical study reports and resolution of data discrepancies.
Providing clinical trial support, guidance, and direction to Clinical Trial Assistant(s) (CTAs) assigned to clinical studies.
Preparation and tracking of study participant enrollment projections vs. actuals and study budgets.
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
BSc
Operations
Proficient
1
Redwood City, CA 94063, USA