Senior Clinical Program Manager

Duties and Responsibilities

• Support Clinical Operations with GCP guidance and best industry practices.
• Lead or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc in compliance with International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP), and regulatory requirements.
• Contribute to the management of 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 company standards, GCP, and regulatory requirements.
• Partner cross-functionally and with QA on remediation plans and continuous improvement of GCP systems, investigations, CAPAs, 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, Bachelor's, or Master's degree in biological sciences or a health-related field required.
• 10+ years (Sr. CPM) direct Clinical Operations and/or Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry, or Clinical Research-related experience.
• Strong working knowledge of FDA Regulations, GCP, and ICH Guidelines, and current industry practices.
• 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.
• Able 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%).

Preferred Skills

• Oncology experience, early and/or late stage.
• Knowledge and/or familiarity with Ex-US region(s) regulations and requirements.