Clinical Operations Director
2 hours ago
True North Consulting is seeking a highly experienced and skilled Associate Director to lead our clinical monitoring oversight program. As a key member of our clinical operations team, you will be responsible for overseeing and implementing a global sponsor oversight monitoring program within the clinical operations department.
Key Responsibilities:- Manage global oversight monitoring for the company-sponsored clinical studies or programs, ensuring monitoring oversight quality follows SOPs, regulations, and ICH/GCP guidelines.
- Provide leadership, mentorship, and line management to a global sponsor oversight monitoring team of company oversight monitors (also known as sponsor CRAs).
- Partner with teams, CROs, and cross-functional teams to facilitate improved clinical quality and monitoring activities.
- Develop and implement risk mitigation strategies to ensure proactive management of protocol/GCP compliance and data quality by the CRO and investigator sites.
- Establish oversight monitoring performance metrics to ensure consistency of delivery of the global oversight monitors across the department.
- Point of escalation for site and CRO quality performance concerns, data quality risks, and GCP non-conformities identified through sponsor oversight monitoring visits.
- Manage site and study CAPAs to quality resolution and closure and implement preventative risk mitigations and CAPA effectiveness checks.
- Develop oversight monitoring guidance documents, such as the co-monitoring plan, vendor oversight plan, global monitoring tools, and templates.
- Perform quality review checks on key clinical documents, such as clinical protocols, informed consent forms, case report forms, clinical monitoring plans, monitoring reports, and so on.
- Share best practices from monitors/regions to raise the quality of data and protocol compliance at all sites.
- Perform oversight monitor quality control visits (yearly or as needed).
- Support clinical operations projects, infrastructure, training, and processes, such as SOP development and review, management of clinical systems, oversight of clinical metrics tracking and reporting, inspection readiness efforts, and audit-ready Trial Master Files reviews (internal and at CRO).
- BA/BS degree in Health or Life Sciences required, advanced degree preferred.
- A minimum of 7+ years of experience in Clinical Operations roles within the Pharmaceutical and/or Medical Device Industry, with heavy concentration within clinical trial management and monitoring.
- A minimum of 2+ years of experience as a manager/leader.
- A minimum of 3+ years of experience as a field monitor with a Pharmaceutical/Medical Device company or CRO.
- Exceptional collaboration, communication, and interpersonal skills.
- Demonstrated ability to effectively manage external vendors and CROs.
- Advanced proficiency in Microsoft Office and Microsoft Project or Smartsheets.
- Reliable, self-motivated, team player.
- Detail-oriented with excellent organizational skills.
- Ability to effectively manage multiple tasks and competing priorities.
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