Temp Clinical Program Manager

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Operations Professional. As a Clinical Program Manager you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management of Revolution Medicines (RevMed) clinical trials.

Required Skills Experience and Education:

• RN or Bachelors or Masters degree in biological sciences or health-related field required

• 8 years (CPM) or 10 years (Sr. CPM) direct Clinical Operations experience in the pharmaceutical or biotech industry preferably in Clinical Operations or Clinical Research-related experience. Relevant indirect experiences may also meet the requirement.

• Minimum of 4 years (CPM) or minimum of 6 years (Sr. CPM) of cross-functional study management or related leadership experience in life sciences including multiple years experience managing project teams

• Strong working knowledge of FDA Regulations ICH Guidelines and GCP

• Proven ability to successfully start-up manage and close-out clinical trials including authoring clinical study and regulatory documentation and SOPs.

• 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

• Be solution-oriented by anticipating obstacles and difficulties and proactively providing risk assessment and mitigation strategies to achieve project goals

• Excellent written/verbal communication and interpersonal skills

• High sense of priority and commitment to excellence in the successful execution of deliverables

• Ability to analyze operational data contribute with a mind on quality timeliness and fiscal responsibility make and drive decisions 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 (25%)

• Adhere to Clinical Standard Operating Procedures (SOP) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines

• Be a team leader providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgets

• Partner with cross-functional teams to manage adjust and revise project timelines and budgets as needed

• Analyze data health metrics to be shared with stakeholders

• Actively partner with cross-functional teams and vendors to drive the query resolution and data listings review process to meet objectives in a timely and efficient process

• Conduct risk management contingency and scenario planning

• Supervise communicate project status/issues and problem solve to ensure project team goals are met

• Participate in the development of all study-related documentation including study protocols

• Actively contributes in the selection and management of contract research organizations (CROs) and/or vendors including development of requests for proposals (RFPs)

• Use all available tools to track oversee and communicate on program status to all key stakeholders

• Participate in other Clinical Operations activities as appropriate

CPM Responsibilities (will also need to meet the General Responsibilities):

• Leads a larger more complex trial with some oversight from senior members of Clinical Operations

• With minimal support lead cross-functional Clinical Study Execution Team (CSETs)

• Participate in and contribute to SOP development implementation and training

• Support junior team members through mentorship.

• Demonstrate the ability to lead and manage multiple complex clinical trials within one or multiple programs with limited oversight.

• Independently lead Clinical Study Execution Team (CSETs) and influence relevant stakeholders both internally and externally including management.

• May lead interdepartmental strategic business initiatives as well as spearhead certain SOP development and training.

• May provide input into strategic and operational short- and long-term therapeutic area development as appropriate including supporting alignment and communication to other team members upon implementation.

• Assists in the hiring development and retention of top talent within the team. Coaches direct report(s) on their performance development and career interests.

Preferred Skills:

• 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 Ex-US region(s) clinical trial operations

• Some experience managing direct reports(s) for Sr. CPM role and mentoring experience for CPM.

This is a contract position that will be employed through a third-party recruiting agency. The agency will provide the pay range which will be based on several factors including job-related skills experience market conditions and relevant education or training.

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 the 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 ourCCPA Noticeand.For additional information please contact.

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