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Program Manager

4 months ago

United Kingdom Umbrex Full time

Our client, a leader in clinical operations, is seeking a Program Manager to address compliance gaps in line with the new European Medicines Agency (EMA) guidelines for computerized systems and electronic data in clinical trials. This is an exciting opportunity to lead key initiatives that are critical to ensuring compliance with these new standards.


The ideal candidate is a seasoned program manager with a solid background in clinical trials and quality management.


Key Responsibilities:

  • Lead and manage 10 initiatives currently in the planning stages to close compliance gaps related to the new EMA guidelines.
  • Ensure all clinical trials adhere to the new EMA Guideline for Computerized Systems and Electronic Data.
  • Ensure that all project milestones and deliverables are met on time and within budget.
  • Develop, implement, and monitor compliance strategies to adhere to EMA guidelines.
  • Collaborate with cross-functional teams, including clinical, quality, regulatory, and IT departments, to ensure cohesive and comprehensive project execution.
  • Maintain up-to-date knowledge of GXP regulations, including GMP, GCP, and GLP, to ensure all project activities comply with these standards.
  • Oversee and ensure quality control throughout the project lifecycle.
  • Identify potential risks and develop mitigation strategies to ensure project success.


Qualifications:

  • Proven experience as a Program Manager in clinical trials, with a strong focus on quality and regulatory compliance.
  • In-depth understanding of GXP regulations, including GMP, GCP, and GLP.
  • Demonstrated experience in managing projects related to EMA guidelines for computerized systems and electronic data.
  • Exceptional project management skills, including planning, execution, monitoring, and closing projects.
  • Strong analytical and problem-solving abilities, with a keen attention to detail.
  • Excellent communication and interpersonal skills, capable of effectively collaborating with diverse teams.
  • Ability to manage multiple initiatives simultaneously and prioritize tasks effectively.


Start: Mid June

Duration: 6 months

Time commitment: 3 days a week

Location: Primarily remote with some travel to the US and UK

Expected range: $125 - $150 per hour

Project ID#: 4196


*This is a contract role that does not offer health benefits