We are seeking a Clinical Operation Manager to oversee and manage the execution of clinical trials, ensuring compliance with regulatory requirements and alignment with company objectives. This role is pivotal in coordinating clinical operations, supporting global clinical trial execution, vendor management, and data integrity to facilitate successful regulatory submissions.
The Clinical Operation Manager will work closely with internal teams, CROs, regulatory bodies, and external partners to ensure that all clinical trials are conducted efficiently and in compliance with FDA and international regulations.
Key Responsibilities
In collaboration with Head of clinical operations and/or Medical Director,
responsible for comprehensive study management
Lead core team meetings for assigned studies, ensuring goals and deliverables are defined, and issues, decisions, risks, and actions are appropriately tracked
Responsible for managing project-specific vendors, including Study Committees, CRO/ARO, Core Labs, and DSMBs/CECs.
Oversee and support the development of key study documents including, but not limited t,o study protocols and related amendments, study plans and procedure manuals, project tools, training materials, Informed Consent Forms, and Clinical Study Reports.
Accountable for the conduct of clinical study following the approved project plans, budgets, SOPs, and applicable regulations
Support analysis and development of action plans for investigational sites, vendor management, non-compliance, and administrative issues
Requirements: Bachelor of Science (BS) degree in Science, Engineering, or related medical/scientific field
Minimum of 8+ years relevant experience
Minimum of 5+ years of experience in clinical research with at least two years in the medical device industry in a leadership role
Expertise with GCP and regulatory compliance guidelines for clinical trials
Polished communication and presentation style
High attention to detail and accuracy; Excellent prioritization, organizational skills, and advanced, metric-driven project management skills
Positive, self-starter, willing to work in a highly fast-paced environment, looking for growth and making a difference in patient lives.
Excellent interpersonal communication skills; Works effectively on cross-functional teams
Willingness and ability to travel up to 35% to support study initiatives, as required
This position is open to all candidates.