Job Overview:
A Clinical Study Manager is crucial for the planning, execution and management of a clinical study for an innovative diagnostic device as it progresses toward regulatory submission.
You will oversee trial protocols, ethics and governance submissions, quality systems, and regulatory compliance to ensure trials are delivered to the highest standard.
Key Responsibilities:
* Develop, review and finalize study protocols for ethics submission
* Draft and manage investigational brochures for ethics and regulatory approval
* Create, submit and manage ethics and governance applications and amendments
* Manage trial documentation, case report forms, reports and essential files
* Identify, assess and oversee trial sites, including site visits and investigator engagement
* Oversee participant recruitment and ensure study milestones are met
* Manage study operations including clinical supply logistics, safety monitoring, adverse event reporting and audits
* Apply ISO9001 principles and contribute to SOP development and quality documentation
* Collaborate with research staff, investigators, industry partners and regulatory authorities
* Lead cross-functional teams, manage timelines, budgets and project deliverables
* Provide verbal and written reports to management and stakeholders
Bachelor of Science/Biomedical Science or related discipline (essential) and minimum 3 years' senior level experience in medical device or diagnostics clinical trials required.