Associate Director, Clinical Operations Compliance & Training

Associate Director, Clinical Operations Compliance & Training

W2 Contract-to-Hire

Salary Range: $208,000 - $239,200 per year

Location: Redwood City, CA - Hybrid 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 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 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 the company standards, GCP, and regulatory requirements.
• Partner cross-functionally and with QA on remediation plans and continuous improvement of GCP systems, as well as 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, 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, 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 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, Clinical Operations Training, GCP compliance, Good Clinical Practices, ICH Guidelines, International Conference on Harmonization, FDA regulations, clinical study management, regulatory requirements, compliance metrics, business metrics, inspection readiness, clinical trial lifecycle, audit responses, remediation plans, continuous improvement, GCP systems, quality assurance, cross-functional collaboration, SOP development, SOP authoring, clinical SOPs, oversight activities, monitoring oversight, risk assessment, risk mitigation, project management, stakeholder communication, deliverable tracking, clinical quality assurance, pharmaceutical industry experience, biotech industry experience, clinical research, operational data analysis, Microsoft Office Suite, Outlook, MS Word, Excel, PowerPoint, MS Project, Smartsheet, oncology clinical trials, early stage clinical trials, late stage clinical trials, Ex-US regulations, international regulations, clinical program management, GCP infrastructure, compliance training programs, clinical operations best practices, project status tracking, interdisciplinary team collaboration, written communication, verbal communication, interpersonal skills

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.