Bayside Solutions

Compensation

Full Description

Sr. Clinical Program Manager, Clinical Operations, Compliance & Training W2 Contract-to-Hire Salary Range: $166,400 - $187,200 per year Location: Redwood City, CA - Hybrid Role Job Summary: As a Sr. Clinical Program Manager (Sr. CPM), you will be in a key role in the Clinical Operations, Compliance, and Training function in Clinical Operations to support the development and continuous improvement of GCP infrastructure using knowledge and experience with clinical study management, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP), and regulatory requirements. Duties and Responsibilities: • Support Clinical Operations with GCP guidance and best industry practices. • Contribute to managing business and compliance metrics to assess and continuously improve oversight and inspection readiness throughout the clinical trial lifecycle. • Support Clinical Operations Inspection Readiness activities. • Contribute to Clinical Operations training programs to deliver standards, GCP, and regulatory requirements. • Partner cross-functionally with QA on remediation plans, continuous improvement of GCP systems, and audit responses. • Communicate deliverable status/issues and problem-solve to ensure functional goals are met. • Use all available tools to track, oversee, and communicate on project status to all key stakeholders. • Participate in other Clinical Operations Compliance & Training activities as assigned. Requirements and Qualifications: • RN or Bachelor's or Master's degree in biological sciences or a health-related field required. • 10+ years of direct Clinical Operations and/or Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience. • Strong working knowledge of FDA Regulations, GCP, and ICH Guidelines. • Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs, ensuring compliance with GCP and regulatory requirements. • Experience with the development and monitoring of oversight activities • Thrives in a collaborative team setting that demonstrates the 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, multitask, 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%) Preferred Qualifications: • Oncology experience, early and/or late stage • Knowledge and/or familiarity with Ex-US region(s) regulations and requirements Desired Skills and Experience Clinical Operations, Compliance, Training, FDA Regulations, GCP, ICH Guidelines, Inspection Readiness, remediation plans, continuous improvement, SOP, Microsoft Office Suite, Oncology, travel Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.