Hybrid Clinical Program Manager, Oncology Trials

Openkrill

United States

Remote

USD 129,000 - 160,000

Full time

8 days ago

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Job summary

Revolution Medicines is seeking an experienced Clinical Operations leader to guide all aspects of oncology trial execution. You will manage cross-functional teams, vendors, and timelines, driving data quality and regulatory readiness across studies.

Ideal candidate brings 8+ years in Clinical Operations, strong FDA/ICH/GCP knowledge, and a track record of start-up, execution, and close-out of trials. Travel up to 25% is expected, with onsite work at Redwood City HQ.

Qualifications

  • RN or Bachelor’s or Master’s degree in biological sciences or health-related field required.
  • 8+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
  • Minimum of 4 years of cross-functional study management or related leadership experience in life sciences.
  • Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
  • Proven ability to 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.
  • Thrive in a collaborative team setting with fast pace and innovative approaches.
  • Excellent written/verbal communication and interpersonal skills.

Responsibilities

  • Adhere to Clinical SOPs, GCP and ICH Guidelines.
  • Lead and oversee trial management within timelines and program budgets.
  • Partner with cross-functional teams to manage timelines and budgets.
  • Analyze data health metrics for stakeholders.
  • Drive query resolution and data listings review processes with vendors.
  • Conduct risk management and contingency planning.
  • Supervise and communicate project status and problem solve to meet goals.
  • Contribute to study documentation including protocols and SOPs.
  • Select and manage CROs/vendors, including RFPs.
  • Track program status and communicate with key stakeholders.
  • Lead larger, more complex trials with senior oversight.
  • Mentor junior team members and support SOP development and training.

Skills

Cross-functional leadership
GCP knowledge
FDA regulations
CRO/vendor management
Risk assessment
Communication skills
MS Office Suite
Travel

Education

RN or Bachelor’s/Master’s in biological sciences

Tools

MS Project
Smartsheet
eTMF / EDC / IRT / CTMS portals

Job description

Revolution Medicines is seeking an experienced Clinical Operations leader to guide all aspects of oncology trial execution. You will manage cross-functional teams, vendors, and timelines, driving data quality and regulatory readiness across studies.

Ideal candidate brings 8+ years in Clinical Operations, strong FDA/ICH/GCP knowledge, and a track record of start-up, execution, and close-out of trials. Travel up to 25% is expected, with onsite work at Redwood City HQ.

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