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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 who will be responsible for managing and overseeing clinical trials and research projects from initiation to completion. The ideal candidate will ensure that all clinical projects are conducted in compliance with regulatory requirements, company policies, and industry standards. You will coordinate cross-functional teams, manage timelines, budgets, and resources, and ensure effective communication among stakeholders. The Clinical Project Manager will also be responsible for identifying and mitigating risks, ensuring data integrity, and maintaining high-quality standards throughout the project lifecycle. In this role, you will collaborate closely with clinical research associates, investigators, regulatory affairs specialists, and other stakeholders to ensure the successful execution of clinical trials. You will be expected to develop detailed project plans, monitor progress, and provide regular updates to senior management. Additionally, you will be responsible for ensuring that all project documentation is accurate, complete, and compliant with applicable regulations. The successful candidate will have strong leadership skills, excellent organizational abilities, and a proven track record of managing clinical projects effectively. You should be detail-oriented, proactive, and capable of handling multiple projects simultaneously. Strong communication and interpersonal skills are essential, as you will be required to interact with various internal and external stakeholders. As a Clinical Project Manager, you will also be responsible for ensuring that clinical trials are conducted ethically and in accordance with Good Clinical Practice (GCP) guidelines. You will oversee the preparation and submission of regulatory documents, manage relationships with regulatory authorities, and ensure timely reporting of adverse events and other critical information. You will also be expected to stay current with industry trends, regulatory changes, and best practices in clinical project management. Continuous improvement and innovation will be key aspects of your role, as you will be encouraged to identify opportunities for process enhancements and implement solutions to improve efficiency and effectiveness. This position requires a high level of professionalism, integrity, and accountability. You will be expected to maintain confidentiality and handle sensitive information with discretion. The Clinical Project Manager will also be responsible for mentoring and training junior team members, providing guidance and support to ensure their professional growth and development. If you are passionate about clinical research, have a strong background in project management, and are committed to delivering high-quality results, we encourage you to apply for this exciting opportunity. Join our dynamic team and contribute to the advancement of medical research and patient care.

Responsibilities

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  • Plan, execute, and manage clinical trials from initiation to completion.
  • Ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
  • Coordinate cross-functional teams and manage project timelines and budgets.
  • Identify, assess, and mitigate project risks and issues.
  • Maintain accurate and complete project documentation and records.
  • Communicate effectively with internal and external stakeholders.
  • Prepare and submit regulatory documents and reports.
  • Mentor and train junior team members and provide guidance and support.

Requirements

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  • Bachelor's degree in life sciences, healthcare, or related field; advanced degree preferred.
  • Minimum of 3-5 years of experience managing clinical trials or research projects.
  • Strong knowledge of clinical trial processes, regulatory requirements, and GCP guidelines.
  • Excellent organizational, planning, and project management skills.
  • Strong communication, interpersonal, and leadership abilities.
  • Ability to manage multiple projects simultaneously and meet deadlines.
  • Proficiency in clinical trial management software and tools.
  • Certification in clinical research or project management (e.g., PMP, CCRP) preferred.

Potential interview questions

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  • Can you describe your experience managing clinical trials from initiation to completion?
  • How do you ensure compliance with regulatory requirements and GCP guidelines?
  • What strategies do you use to manage project timelines and budgets effectively?
  • Can you provide an example of how you identified and mitigated a significant project risk?
  • How do you handle communication and coordination among cross-functional teams?