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Title

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Clinical Trial Manager

Description

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We are looking for a dedicated and experienced Clinical Trial Manager to join our dynamic team in the healthcare industry. The ideal candidate will be responsible for overseeing the execution of clinical trials from start to finish, ensuring they are conducted in compliance with regulatory standards and within the stipulated timelines. This role involves coordinating with various departments, including regulatory affairs, data management, and pharmacovigilance, to ensure the smooth operation of clinical trials. The Clinical Trial Manager will also be responsible for budget management, site selection, and ensuring the trials adhere to Good Clinical Practice (GCP) guidelines. With a focus on innovation and efficiency, the successful candidate will play a crucial role in advancing medical research and bringing new therapies to market. This position requires a strategic thinker with excellent organizational and leadership skills, who can navigate the complexities of clinical trials while maintaining a commitment to ethical research practices and patient safety.

Responsibilities

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  • Develop and implement clinical trial strategies.
  • Coordinate with internal departments and external partners to ensure trial objectives are met.
  • Oversee the selection and management of clinical trial sites.
  • Ensure compliance with regulatory requirements and GCP guidelines.
  • Manage trial budgets and resources effectively.
  • Monitor trial progress and make adjustments as necessary.
  • Prepare and submit trial-related regulatory documents.
  • Lead cross-functional teams to ensure successful trial execution.
  • Analyze and report on trial data.
  • Address and resolve any issues that arise during the trial.

Requirements

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  • Bachelor's degree in life sciences or related field.
  • Minimum of 5 years of experience in clinical trial management.
  • Strong understanding of regulatory requirements and GCP.
  • Excellent project management and leadership skills.
  • Ability to manage multiple trials simultaneously.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Experience with electronic data capture (EDC) systems.
  • Willingness to travel as required.
  • Certification in Clinical Trial Management preferred.

Potential interview questions

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  • Can you describe your experience with managing clinical trials?
  • How do you ensure compliance with regulatory requirements and GCP guidelines?
  • Describe a challenging situation you faced in a clinical trial and how you resolved it.
  • How do you manage your trial budgets and resources?
  • What strategies do you use to ensure successful trial execution?