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.
The Opportunity:
This is a unique opportunity for an entry-level Clinical Operations Professional. As a Clinical Trial Management Associate (CTMA), you will be responsible for acting as an integral member of the clinical study team(s) and will be tasked to support the execution and management of Revolution Medicines (RevMed) clinical trials. You will play a critical role in ensuring trials and studies align with all applicable standards.
Responsibilities:
-
Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
-
Support managers in conducting clinical trials of higher complexity or volume.
-
May assist in the selection, coordination, and management of Contract Research Organizations (CROs) or other clinical trial vendors (e.g., IRT, imaging vendor, central labs, etc.).
-
Partner with the Clinical Operations Study Lead in the development, review, distribution, and archiving of study specific documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.).
-
Conduct sponsor oversight activities, such as review Monitoring Reports and other study documentation, or central review of study drug accountability, as required.
-
Provide mentorship and support to Clinical Trial Assistant I/Clinical Trial Assistant II (CTA/CTA II)in the set-up and management of clinical trial documentation to be filed in the Trial Master File (TMF). Follow up on assigned team action items and identification, escalation, and resolution of issues as needed.
-
Assess adequacy/feasibility of potential clinical investigators and sites, including qualification of investigators, evaluation of facilities, personnel, patient referral base, and adherence to GCP.
-
Contributes to ensuring the review of routine data surveillance and data listings, and assist in the preparation of interim and final Clinical Study Reports and resolution of data discrepancies are conducted.
-
Prepare and track study participant projections vs actuals (e.g., participant enrollment, assessments).
-
Interface with individuals in other functional areas to address routine study issues.
-
Serve as a resource to CTA Is/CTA IIs; may assist in training.
-
Support other Clinical Operations activities as appropriate.
Required Skills, Experience and Education:
-
RN or Bachelor’s degree in biological sciences or health-related field required.
-
3-5 years direct experience preferred and/or relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
-
Good working knowledge of FDA Regulations, ICH Guidelines, and GCP.
-
Experience in selection of CROs/vendors and management of external resources.
-
Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
-
Excellent written/verbal communication and interpersonal skills.
-
High sense of urgency and commitment to excellence in the successful execution of deliverables.
-
Ability to multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
-
Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint; MS Project and or Smartsheet a plus.
-
Travel may be required (~10%).
Preferred Skills:
-
Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
-
Oncology experience, early and/or late stage, strongly preferred.
-
Knowledge and/or familiarity with EMEA/APAC region(s) clinical trial operations.
-
Attention to detail.
The base salary range for this full-time position is $87,000 to $104,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. 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-JC1