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Clinical Research Program Manager

2 months ago

Baltimore, Maryland, United States InsideHigherEd Full time
Job Summary

We are seeking a highly skilled and experienced Clinical Research Program Manager to join our team at InsideHigherEd. The successful candidate will be responsible for overseeing the day-to-day operations of our clinical research programs, ensuring compliance with regulatory requirements, and providing strategic leadership to our research team.

Key Responsibilities
  • Program Management
    • Develop and implement strategic plans to achieve research program goals and objectives.
    • Oversee the development and implementation of Standard Operating Procedures (SOPs) to ensure compliance with regulatory requirements.
    • Manage and coordinate research projects, including budgeting, scheduling, and resource allocation.
  • Regulatory Compliance
    • Ensure compliance with regulatory requirements, including FDA regulations, IRB guidelines, and other applicable laws and regulations.
    • Develop and implement quality assurance and quality control processes to ensure data integrity and accuracy.
    • Conduct regular audits and assessments to ensure compliance with regulatory requirements.
  • Team Leadership
    • Provide strategic leadership and guidance to research team members, including research coordinators, research assistants, and other support staff.
    • Develop and implement training programs to ensure research team members have the necessary skills and knowledge to perform their duties.
    • Conduct regular performance evaluations and provide feedback to research team members.
Requirements
  • Education
    • Bachelor's degree in a health-related field, such as public health, health administration, or a related field.
  • Experience
    • At least 8 years of experience in clinical research, including experience in program management, regulatory compliance, and team leadership.
  • Skills
    • Excellent organizational and leadership skills.
    • Strong communication and interpersonal skills.
    • Ability to work independently and as part of a team.
    • Knowledge of regulatory requirements, including FDA regulations and IRB guidelines.
Preferred Qualifications
  • Education
    • Master's degree in a health-related field, such as public health, health administration, or a related field.
  • Experience
    • Experience in budgeting and financial management.
    • Experience in grant writing and fundraising.
  • Skills
    • Experience with electronic data capture systems and other research software.
    • Experience with quality assurance and quality control processes.