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Title

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Clinical Project Manager

Description

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We are looking for a Clinical Project Manager to lead and coordinate clinical research projects from initiation through to completion. This role is critical in ensuring that clinical trials are conducted in accordance with regulatory requirements, timelines, and budgets. The Clinical Project Manager will serve as the primary point of contact for internal teams, external vendors, and clinical sites, ensuring seamless communication and execution of study protocols. The ideal candidate will have a strong background in clinical research, excellent organizational skills, and the ability to manage multiple projects simultaneously. You will be responsible for developing project plans, managing budgets, and ensuring that all aspects of the clinical trial process are executed efficiently and effectively. This includes oversight of site selection, patient recruitment, data collection, and reporting. You will also be expected to identify and mitigate risks, resolve issues as they arise, and ensure that all documentation is complete and audit-ready. Strong leadership and communication skills are essential, as you will be leading cross-functional teams and collaborating with stakeholders across various departments. This position offers the opportunity to work on cutting-edge medical research and contribute to the development of new therapies that can improve patient outcomes. If you are passionate about clinical research and have a proven track record of managing complex projects, we encourage you to apply.

Responsibilities

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  • Lead and manage clinical trials from initiation to close-out
  • Develop and maintain project timelines and budgets
  • Coordinate with cross-functional teams and external vendors
  • Ensure compliance with regulatory guidelines and protocols
  • Monitor site performance and patient recruitment progress
  • Prepare and review study documentation and reports
  • Identify project risks and implement mitigation strategies
  • Serve as the primary contact for clinical sites and stakeholders
  • Oversee data collection, quality control, and reporting
  • Support audits and inspections by regulatory authorities

Requirements

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  • Bachelor’s degree in life sciences or related field
  • Minimum 3 years of experience in clinical project management
  • Strong knowledge of GCP, ICH guidelines, and FDA regulations
  • Excellent organizational and time management skills
  • Ability to manage multiple projects simultaneously
  • Strong communication and leadership abilities
  • Experience with clinical trial management systems (CTMS)
  • Detail-oriented with strong problem-solving skills
  • Ability to travel as needed
  • Advanced degree or PMP certification is a plus

Potential interview questions

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  • Do you have experience managing clinical trials?
  • Are you familiar with GCP and ICH guidelines?
  • Can you describe a challenging project you managed?
  • What clinical trial management systems have you used?
  • How do you handle project delays or budget overruns?
  • Are you willing to travel for site visits?
  • Do you have experience working with CROs or vendors?
  • What therapeutic areas have you worked in?
  • How do you ensure regulatory compliance in your projects?
  • What is your approach to team leadership and coordination?