Sr. Compliance Manager - FSP (Remote - US)

A Bachelor's degree is preferred, along with experience in Regulatory Authority Inspections (FDA, MHRA, Health Canada, EMEA, etc.). Candidates must have at least 6 years of clinical research experience in the pharmaceutical or biotechnology field and solid knowledge of GCP compliance, regulatory inspection readiness, and study execution processes. Experience with CROs, outsourced clinical trial activities, and sponsor experience within a GCP environment is required, as is solid knowledge of drug development and clinical trial processes, including related standards and documents. Experience in clinical trials systems management and oversight (Veeva preferred), proven awareness of sponsor oversight requirements and regulations, and strong problem-solving, negotiation, and collaborative team-building skills are also necessary. Excellent project management and communication skills are essential for risk assessment, prioritization, initiative, and meeting deadlines in a fast-paced environment. An equivalency of appropriate education, training, and/or directly related experience may be considered.