Senior Clinical Program Manager, Clinical Operations Compliance and Training

Senior Clinical Program Manager, Clinical Operations Compliance and Training

W2 Contract

Pay Rate: $80 - $110 per hour

Location: Redwood City, CA - Remote Role

Job Summary:

This is a unique opportunity for a Clinical Operations Compliance Professional. As a Sr. Clinical Program Manager (Sr. CPM), you will be in a key role in the Clinical Operations, Compliance and Training function in our Clinical Operations to support the development and continuous improvement of GCP infrastructure using knowledge and experience with clinical study management, clinical compliance, clinical quality, 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.
• 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 the oversight and inspection readiness throughout the clinical trial lifecycle.
• Support Clinical Operations Inspection Readiness activities.
• Contribute to Clinical Operations training programs to deliver our 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 or 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.
• 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.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as Inc.'s candidate.

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