Revolution Medicines
Overview
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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity This is a unique opportunity for a Clinical Trial Manager (CTM). You will be responsible for independently managing one or more Phase 1-3 studies or complex components of larger trials with cross-functional oversight and vendor management. This position will report into the Director, Clinical Operations.
Responsibilities
Apply advanced expertise and exercise considerable latitude to determine objectives and to develop effective solutions to guide the successful completion of complex assignments under limited supervision.
Participate in the Clinical Study Execution Team (CSET) discussion and may lead aspects of the meeting agenda as it pertains to vendors, study metrics, etc.
Drive site activation and document readiness activities; analyze enrollment and operational metrics, supporting study lead in decision-making.
Participate and sometimes lead meetings internally and externally with CROs, vendors, and multi-functional teams with minimal supervision.
Lead TMF reconciliation and inspection readiness activities.
Support the review of study documents such as protocols, ICFs, CRFs, monitoring plans, etc.
Lead department process improvement initiatives.
Participate in CROs/vendor trainings as it relates to a limited aspect of study requirements.
Manage the CRO and some ancillary vendors and ensure deliverables.
May participate in the interview process for similar or junior roles within Clinical Operations.
Mentor and support Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs).
Follow up and follow through on team action items and identification, escalation, and resolution of issues as needed.
Review and identify trends when performing routine data surveillance of data listings, and support in the preparation of interim and final Clinical Study Reports and resolution of data discrepancies.
Support other Clinical Operations activities as appropriate.
Required Skills, Experience and Education
BS, BA, or RN in a relevant scientific discipline.
5-7+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
Advanced knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.
Strong communication and coordination skills; global trial experience and strong operational judgement.
Proactive contributor to trial execution and issue resolution, with strong ownership of responsibilities for complex studies with multiple sites.
High sense of priority and commitment to excellence in the successful execution of deliverables.
Ability to analyze operational data, perform with an emphasis on quality, timeliness and multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
Travel may be required (~15%).
Preferred Skills
Decision-making skills.
Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
Oncology experience, early and/or late stage, strongly preferred.
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The Opportunity This is a unique opportunity for a Clinical Trial Manager (CTM). You will be responsible for independently managing one or more Phase 1-3 studies or complex components of larger trials with cross-functional oversight and vendor management. This position will report into the Director, Clinical Operations.
Responsibilities
Apply advanced expertise and exercise considerable latitude to determine objectives and to develop effective solutions to guide the successful completion of complex assignments under limited supervision.
Participate in the Clinical Study Execution Team (CSET) discussion and may lead aspects of the meeting agenda as it pertains to vendors, study metrics, etc.
Drive site activation and document readiness activities; analyze enrollment and operational metrics, supporting study lead in decision-making.
Participate and sometimes lead meetings internally and externally with CROs, vendors, and multi-functional teams with minimal supervision.
Lead TMF reconciliation and inspection readiness activities.
Support the review of study documents such as protocols, ICFs, CRFs, monitoring plans, etc.
Lead department process improvement initiatives.
Participate in CROs/vendor trainings as it relates to a limited aspect of study requirements.
Manage the CRO and some ancillary vendors and ensure deliverables.
May participate in the interview process for similar or junior roles within Clinical Operations.
Mentor and support Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs).
Follow up and follow through on team action items and identification, escalation, and resolution of issues as needed.
Review and identify trends when performing routine data surveillance of data listings, and support in the preparation of interim and final Clinical Study Reports and resolution of data discrepancies.
Support other Clinical Operations activities as appropriate.
Required Skills, Experience and Education
BS, BA, or RN in a relevant scientific discipline.
5-7+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
Advanced knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.
Strong communication and coordination skills; global trial experience and strong operational judgement.
Proactive contributor to trial execution and issue resolution, with strong ownership of responsibilities for complex studies with multiple sites.
High sense of priority and commitment to excellence in the successful execution of deliverables.
Ability to analyze operational data, perform with an emphasis on quality, timeliness and multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
Travel may be required (~15%).
Preferred Skills
Decision-making skills.
Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
Oncology experience, early and/or late stage, strongly preferred.
#J-18808-Ljbffr