Country Study Operations Manager I (Secondment - 12 Months)

Pfizer • New York City, NY

2d • Remote

About The Position

WHY PATIENTS NEED YOU Reporting to the Research & Development division, you will be integral in bridging evidence-based medical decision support with colleagues and stakeholders to enhance health and treatment outcomes. By developing frameworks to ensure our evidence is scientifically robust, providing unbiased and medically necessary expertise, or investigating data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Your work will support better health outcomes, ensuring that our evidence is sound and that healthcare decisions are informed and safe for patients. WHAT YOU WILL ACHIEVE Provide guidance and lead/co-lead moderately complex projects, managing time and resources effectively. Apply skills and discipline knowledge to contribute to departmental work and resolve moderately complex problems independently. Make decisions in non-standard situations, developing new options guided by policies, and operate independently in ambiguous situations. Review your own work, seek directional review from others, and mentor colleagues by reviewing their work. Exercise judgment using knowledge and experience, potentially becoming a resource for others. Oversee the execution of clinical studies, ensuring the development of realistic and detailed study startup and monitoring plans. Support study startup activities at the country level, including reviewing key documents and addressing regulatory and ethics committee questions. Forecast and manage the Clinical Trial Budget, oversee drug supply management, and ensure the flow of drug supply to sites. Serve as the primary point of contact for study decisions related to the protocol, data collection, and volunteer activities, partnering with key team members to achieve milestones and resolve site-level issues.

Requirements

• Must-Have Applicant s must have a bachelor's degree with at least 5+ years of experience ; OR a master's degree with at least 3+ years of experience ; OR a PhD with 0+ years of experience; OR as associate's degree with 8+ years of experience; OR a high school diploma (or equivalent) and 10+ years of relevant experience .
• Proven experience in the research and development sector of the pharmaceutical industry.
• Background in managing, conducting, or participating in regulatory inspection processes.
• Deep understanding of project management principles, particularly in clinical research.
• Excellent interpersonal skills and the ability to work effectively in a team environment.
• Proficiency in English, both written and verbal.

Nice To Haves

• Experience in early drug development.
• Ability to manage multiple projects simultaneously.
• Excellent communication and presentation skills.
• Experience using common AI tools, including generative technologies such. as ChatGPT or Microsoft Copilot, to support problem solving and enhance.

Responsibilities

• Provide guidance and lead/co-lead moderately complex projects, managing time and resources effectively.
• Apply skills and discipline knowledge to contribute to departmental work and resolve moderately complex problems independently.
• Make decisions in non-standard situations, developing new options guided by policies, and operate independently in ambiguous situations.
• Review your own work, seek directional review from others, and mentor colleagues by reviewing their work.
• Exercise judgment using knowledge and experience, potentially becoming a resource for others.
• Oversee the execution of clinical studies, ensuring the development of realistic and detailed study startup and monitoring plans.
• Support study startup activities at the country level, including reviewing key documents and addressing regulatory and ethics committee questions.
• Forecast and manage the Clinical Trial Budget, oversee drug supply management, and ensure the flow of drug supply to sites.
• Serve as the primary point of contact for study decisions related to the protocol, data collection, and volunteer activities, partnering with key team members to achieve milestones and resolve site-level issues.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level