Senior Study Start-Up Manager

Premier Research; United States; On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

Premier Research seeks a Manager, Start Up to lead staffing and resource planning within Regulatory Submissions and Contracts. You will drive start-up teams to meet timelines, optimize processes, and mentor staff across global studies, ensuring cost efficiency and compliant practices.

You will review metrics, engage in corporate initiatives, and partner with clients to deliver on study start-up goals while maintaining regulatory standards across regions.

Qualifications

• Undergraduate degree or its international equivalent in clinical, science, or a health-related field from an accredited institution; a licensed health-care professional (i.e. registered nurse) or equivalent work experience required.
• 5+ years of clinical research industry experience required.
• 1+ years people management experience.
• Analytic skill set to review metrics and feasibility numbers.
• Working knowledge of FDA, European Regulatory and EC procedures as applicable.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.
• Working knowledge of ICH / GCP regulations.
• Strong knowledge of web-based communication tools for conferences and IT systems.

Responsibilities

• Manages staffing and resources to ensure departmental utilization.
• Drives study start up teams to meet project timelines.
• Assists in determining efficiencies for study start up and essential document maintenance to improve processes.
• Mentors staff and manages HR-related items, training and performance management.
• Presents to clients as needed and contributes to proposal specifications.
• Prepares forecasts for staff utilization and ensures transitions are planned.

Skills

Analytical skills

People management

Regulatory knowledge

Communication skills

Time management

Team player

Education

Undergraduate degree

Health-care professional license

Job description

Premier Research seeks a Manager, Start Up to lead staffing and resource planning within Regulatory Submissions and Contracts. You will drive start-up teams to meet timelines, optimize processes, and mentor staff across global studies, ensuring cost efficiency and compliant practices.

You will review metrics, engage in corporate initiatives, and partner with clients to deliver on study start-up goals while maintaining regulatory standards across regions.