Note: The job is a remote job and is open to candidates in USA. The company is an early-stage medical-device startup entering an important stage of clinical development. The Senior Clinical Project Manager will lead complex clinical studies, oversee study documentation, sites, safety activities, monitoring, reporting, and budgets, while collaborating with stakeholders and helping build scalable clinical processes.
Responsibilities
- Lead complex clinical studies from start-up through closeout
- Develop and oversee protocols, CRFs, informed consent forms, and other key study documentation
- Manage site selection, activation, contracts, and budgets
- Oversee clinical monitoring activities and corrective actions
- Manage study safety activities, including adverse events and safety committee activities
- Develop study training plans and oversee training documentation
- Prepare interim, annual, and final clinical study reports
- Oversee investigational device allocation, distribution, and reconciliation
- Develop and track clinical study metrics and communicate progress to leadership
- Collaborate with investigators, vendors, consultants, and internal stakeholders
- Help mentor and train team members on ICH/GCP and clinical research requirements
- Identify issues, solve problems, and keep clinical programs moving forward
Skills
- 10+ years of clinical research experience
- Bachelor's degree required
- Strong knowledge of GCP, ICH, FDA, ISO, and applicable clinical research regulations
- Experience managing complex clinical studies
- Strong understanding of clinical trial execution and medical terminology
- Highly organized
- Excellent communication
- Problem-solving skills
- Comfortable working independently
- Managing multiple priorities
- Strong MS Office skills
- Science or healthcare-related discipline preferred
Benefits
- Remote work
Company Overview