Senior Clinical Oversight Specialist

2 weeks ago


San Diego, California, United States Clinical Dynamix Full time

The Senior Clinical Oversight Specialist plays a pivotal role in the remote field, acting as the primary liaison for clinical research sites throughout the study lifecycle. This position involves conducting essential qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the performance of the Contract Research Organization (CRO) Clinical Research Associates (CRAs).

Key Responsibilities:

  • Serve as the main sponsor contact for clinical sites, addressing operational and protocol-related inquiries.
  • Conduct both telephone and on-site qualification visits and initiation visits as the representative of the sponsor, adhering to standard operating procedures (SOPs).
  • Ensure that monitoring activities executed by the CRO meet quality standards and comply with the clinical monitoring plan, SOPs, Good Clinical Practice (GCP), and all relevant regulations.
  • Perform on-site quality oversight assessments to evaluate CRO CRA performance and provide additional support to clinical sites as necessary.
  • Contribute to the clinical development strategy and operational elements of the clinical trial protocol, including the development and review of operational plans.
  • Identify potential operational risks and devise mitigation strategies within assigned clinical trials, escalating issues and recommending contingency plans to the Director of Clinical Operations when needed.
  • Oversee monitoring activities, including drafting oversight plans, reviewing monitoring visit reports, and conducting periodic oversight visits to sites and/or vendors to evaluate progress and compliance.
  • Act as a functional area reviewer for global clinical and regulatory submissions.
Qualifications and Experience:
  • A Bachelor’s degree or equivalent in health or life sciences is required.
  • At least 5 years of experience in a lead CRA or monitoring role within a Biotech or Pharmaceutical organization.
  • Willingness to travel within the US and Canada is essential, with an expected travel commitment of approximately 60%.
  • Experience in co-monitoring or CRA line management is advantageous.
  • Strong understanding of the International Conference on Harmonization (ICH) guidelines and GCP regulations is mandatory.
  • Exceptional communication skills are necessary, along with the ability to foster strong relationships with colleagues, cross-functional teams, and CRO/vendor partners, as well as experience in mentoring clinical study personnel and presenting to senior management.
  • Proficient computer skills, including Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and Electronic Data Capture Systems, are required.


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