Clinical Trials Operations Manager

7 days ago

Deerfield Beach, Florida, United States ICONMA Full time

Job Summary:

The Senior Manager, Patient Recruitment will be responsible for developing a new set of patient recruitment and retention services to enable study teams to plan, forecast, and achieve patient enrollment goals.

This includes being the subject matter expert for RWE proposal teams, developing patient recruitment and campaign strategies that leverage client assets and digital solutions.

The role will be responsible for developing and engaging clients for capabilities presentations and solution development through all phases of campaign execution, with a professional services mindset.

Key Responsibilities:

  • Develop and implement a risk-based and flexible approach to quality assurance in compliance with applicable regulatory requirements.
  • Generate and analyze weekly, monthly, and quarterly metrics to track key performance indicators (KPIs).
  • Work with the Operations team to implement, review, and maintain tracking of incidents within clinical trials, advising on corrective actions to be implemented and ensuring completion in a timely manner.
  • Lead the Audit Program management process, including assessment of internal and external operations, and active audit and regulatory inspections.
  • Partner with functional areas in study design, data collection, and analysis, and reporting activities that support quality improvement interventions, transparency, compliance with regulatory standards, and performance monitoring.

Requirements:

  • Comprehensive understanding of GCP, CFR, and ICH guidelines.
  • Significant experience with managing clinical quality activities and in-depth knowledge of clinical operations.
  • Significant experience in clinical trial site/process audits and regulatory inspections.
  • Experience in line management of employees.
  • Experience translating Pharma/Sponsor needs for innovation and creative approaches to quality management.
  • Excellent leadership and interpersonal skills with the ability to effectively work and problem solve within a multidisciplinary team.
  • Excellent verbal and written communication and presentation skills.
  • Demonstrated adaptability, flexibility, independence, and resourcefulness to thrive in a start-up environment.

Education:

BS in a life sciences discipline.

Additional Job Details:

Ensure Standard Operating Procedures (SOPs) and Internal Operating Procedures are reviewed periodically and advise on required updates to ensure compliance with ethical, regulatory, and other relevant frameworks, making recommendations for improvement where appropriate.

Identify appropriate staff SOP training requirements and maintain oversight of training to ensure all clinical trials staff are trained on SOPs.

Build, manage, lead, and motivate a QA team, ensuring that people with the right range of skills and experience are recruited and retained, and that their skills and professional capabilities are maximized.

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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