Clinical Research Nurse enhancing pediatric oncology care at Monash Children's Hospital. Collaborating with medical staff and managing patient flow for effective cancer treatment.
About the role
- Senior Clinical Study Manager supporting Medical Division with clinical studies to enable market access for medical devices. Ensuring compliance and overseeing operations for clinical evidence gathering.
Responsibilities
- Manage day-to-day operations of one or more clinical studies, ensuring compliance with GCP, FDA regulations, and internal procedures.
- Develop and maintain study-specific documents, including protocols, amendments, monitoring plans, and operational guidelines.
- Oversee data collection, validation, and documentation to meet quality standards and timelines.
- Coordinate and support field-monitoring activities; track enrollment curves and study milestones.
- Assess project risks and implement mitigation strategies to ensure deliverables are achieved.
- Initiate and manage research contracts for Investigator-Initiated Studies and ensure alignment with research strategy.
- Drive publication of study results in peer-reviewed journals by collaborating with internal and external stakeholders.
- Maintain dashboards for clinical and non-clinical studies, tracking objectives, timelines, and financial aspects.
- Oversees clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g., CERs, CEPs, PMCFRs, PMCFPs, SSCPs).
- Supporting Marketing in the creation and review of collateral and promotional material to ensure alignment of messaging and claims to regulatory compliance, scientific accuracy, and clinical evidence.
Requirements
- Bachelor’s degree, preferably with Health Sciences or related technical field
- 6+ years of relevant clinical research experience, preferred in clinical study management
- Medical device experience
- Advanced degree (MSc, PhD) in health sciences, biomedical engineering, health outcomes research
- Preferred clinical research or project management certification
Benefits
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
- bonuses
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Senior Clinical Trial Manager overseeing site management and monitoring for biopharmaceutical solutions organization. Responsible for clinical monitoring, patient safety, and regulatory compliance in South Africa.
Associate HR Partner supporting employee operations at CPS Clinical Research Units. Providing HR guidance and managing employee relations in a clinical environment with on - site presence.
Clinical Research Study Assistant involved in Alzheimer's disease research collecting samples and data. Participating in study protocols and maintaining participant interactions.
Oncology Clinical Research Coordinator at WVU managing clinical trials and ensuring protocol compliance. Collaborating with research staff and healthcare providers while advocating for ethical participant care.
Clinical Research Coordinator supporting clinical research for pediatric care at Shriners Children’s. Ensuring compliance with research protocols and collaborating with clinical teams in Pasadena.
Clinical Research Coordinator managing aspects of clinical trials at Winship Cancer Institute. Handling data management, participant interface, and overseeing trial compliance in Atlanta.
Feasibility Manager at Novo Nordisk optimizing clinical trials through data analysis and strategic partnerships across South Africa. Driving site selection and operational readiness for impactful clinical development.
Clinical Research Coordinator managing overall coordination and implementation of clinical trials. Collaborating with investigators to ensure compliance with study protocols and maintaining accurate subject records.
Clinical Research Coordinator independently managing key aspects of clinical trials. Overseeing data management and ensuring compliance with study protocols and regulations.