Senior Clinical Study Manager
$125,600–$179,630 year
Remote · Raleigh, North Carolina, United States or Minneapolis, Minnesota, United States
Job Summary
Senior Clinical Study Manager responsible for planning, executing, and overseeing clinical trials to ensure efficient, ethical, and regulatorily compliant conduct. Lead day-to-day study management, coordinate site initiation and monitoring, manage budgets and timelines, oversee vendor scope of work, ensure quality and regulatory documentation, and engage with sponsors, investigators, and authorities. Develop study documents, oversee regulatory submissions, data analysis, and preparation of clinical study reports, while tracking KPIs and addressing safety issues and protocol deviations. Drive quality, risk mitigation, and compliance with SOPs, GCP, and local regulations; contribute as an SME to business development and proposal documentation.
Required Qualifications
- Bachelor's degree in health sciences or related discipline
- Minimum of 5 years of relevant experience in clinical study planning, preferably within a MedTech-oriented CRO
- Experience maintaining documentation in compliance with FDA and ISO standards
- Ability to independently manage multiple priorities in a fast-paced environment
- Strong organizational, analytical, and problem-solving skills
- Excellent written and verbal communication skills
- Equal opportunity employer statement included in posting
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