Administration and Travel Associate

Found in: Jooble US O C2 - 2 weeks ago


Redwood City CA, United States Revolution Medicines, Inc. Full time

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 scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
This is a unique opportunity for a Clinical Operations Professional who has technical expertise in supporting Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP) and U.Food and Drug Administration (FDA) regulatory requirements. As the Clinical Trial Management Associate of Clinical Operations, this role will report into the Sr. Director of Clinical Operations.
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.
* 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).
* 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.
* 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.
* Ability to travel (~25%).
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.
* Knowledge with MS Suite, Smartsheet.
* Understanding of EMEA/APAC region(s) clinical trial operations.
An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. 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.



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