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Clinical Research Site Manager

Clinical Research Site Manager

The Judge GroupRemote, US
30+ days ago
Job type
  • Permanent
  • Remote
Job description

Our client is currently seeking a Clinical Research Site Manager

This job will have the following responsibilities :

KEY RESPONSIBILITIES

Clinical Trial Management :

  • Oversee and monitor clinical trial activities at investigative sites, ensuring compliance with protocols, regulatory requirements (GCP and ICH), and company standards.
  • Assist in Site Initiation Visits (SIVs) and training of any new site staff added post-Investigator Meeting and study start.
  • Perform site troubleshooting and issue spotting, proactively identifying and resolving challenges to ensure the smooth progress of clinical trials.
  • Collaborate with cross-functional teams internally to address site-related issues and implement effective solutions.

Site Engagement and Relationship Building :

  • Build and maintain strong relationships with investigators, site staff, and key stakeholders to foster a collaborative and supportive environment.
  • Act as a liaison between the company, CRO (Contract Research Organization) and investigative sites, ensuring clear communication and efficient resolution of site-related queries. Provide training and support to site staff, as needed, to enhance their understanding of protocols, procedures, and compliance with requirements.

    • Clinical Data Review and Reporting :

  • Review and verify clinical trial data, ensuring accuracy and completeness in accordance with protocols and regulatory standards.
  • Perform clinical quality review of data and source documents to ensure internal consistency of data and concordance with expected clinical profiles across data sources.
  • Conduct reviews of clinical charts (paper and electronic), source documents, and case report forms.
  • Assist in the development of monitoring tools for use by CRO and other team members.
  • Prepare regular reports on site performance, patient recruitment, and other relevant metrics, providing updates to internal teams and stakeholders.

    • Regulatory Compliance and Documentation :

  • Build and maintain strong relationships with key internal and external stakeholders, including investigators, KOLs (Key Opinion Leaders), CROs, and regulatory agencies.
  • Stay updated on relevant regulations, guidelines, and best practices related to clinical research and ensure site compliance with these standards.
  • Assist in the preparation of regulatory submissions and documentation, collaborating with regulatory affairs teams as necessary.

    • Continuous Improvement and Process Optimization :

  • Identify opportunities for process optimization and improvement in clinical trial conduct, site engagement, and monitoring activities.
  • Contribute to the development and implementation of best practices and standard operating procedures to enhance the efficiency and quality of clinical research operations.

    • QUALIFICATIONS :

  • Bachelor's degree in life sciences, pharmacy, nursing, or related field (Master's degree preferred).
  • Minimum of 5 years of experience in clinical research, with a strong preference for Psychiatry background, preferably in a biotech or pharmaceutical setting.
  • Prior psychometric rater experience a strong plus
  • Strong understanding of GCP (Good Clinical Practice) guidelines, regulatory requirements, and industry standards. CCRC and GCP current certification a strong plus.
  • Excellent communication and interpersonal skills, with the ability to build rapport and maintain positive relationships with diverse stakeholders.
  • Detail-oriented, analytical, and proactive, with the ability to identify issues and implement effective solutions.
  • Proficiency in using clinical trial management systems and related software tools.
  • Willingness to travel to investigative sites on a frequent basis

    • Travel Requirement :

    This position requires regular regional in-state and out-of-state travel, the USA, approximately up to 50 to 75% of the time.

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    Clinical Research Manager • Remote, US