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 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.S. Food and Drug Administration (FDA) regulatory requirements. Oncology experience preferred. As the Clinical Trial Management Associate of Clinical Operations, this role will report into the Sr. Director of Clinical Operations.
Roles and 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.
Required Skills, Experience and Education
- 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.
