Manager, Process Improvement & Training Global Study Operations

Manager, Process Improvement & Training Global Study Operations

W2 Contract

Salary Range: $104,000 - $124,800 per year

Location: San Rafael, CA - Hybrid Role

Duties and Responsibilities:

• Support effective process improvement efforts by collaborating cross-functionally to develop or update processes, work instruction, policies, procedures, playbooks, and best practices.
• Support the design, development, and implementation of Global Study Operations training materials to enhance operationalizing clinical study conduct.
• Partner with key stakeholders to define training needs through the determination of knowledge gaps and needs assessments.
• Support the evaluation of training effectiveness and content review, revising content as needed.
• Identify, develop, and deploy appropriate learning mechanisms and modalities such as instructor-led, web-based, read, and/or blended training.
• Stay abreast of industry best practices and affiliated publications, memberships and technologies to ensure recommended standards are followed and organizational goals are met.

Requirements and Qualifications:

• Knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Preferred Qualifications
• Experience as a training facilitator or related role with a proven track record of leading development and/or organizational effectiveness programs
• Excellent communication, presentation, and facilitation skills; ability to write clearly and summarize information effectively.
• Ability to plan, organize, coordinate, manage, and execute on multiple initiatives simultaneously and effectively navigate ambiguity.
• Experience in eLearning design and development.
• Strong meeting facilitation skills.
• Excellent teamwork, communication, decision-making, and organizational skills.
• Experience with the Microsoft Office suite - Word, Excel, PowerPoint, Outlook, and understanding of Microsoft Office SharePoint.

Preferred Qualifications:

• Bachelor's Degree and 6 years' experience in clinical operations or clinical trial management experience within a pharmaceutical/biotechnology organization.
• Experience within a pharmaceutical/biotechnology organization.
• Master's Degree and 4 years' experience in clinical operations or clinical trial management experience within a pharmaceutical/biotechnology organization.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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