Senior Manager, Clinical Operations - Council of the City of Ryde, Australia - Edwards Lifesciences

Description

Clinical Affairs

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Job Functions:

• Manage and oversee the work of a clinical operations team and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department. Assess knowledge and/or quality gaps of clinical staff and determine appropriate training plans and/or needs
• Oversee the planning of start-up activities (e.g., contracts, scope of work, case report form development, training materials) with accountability for successful completion within scope of project deliverables. Conduct training for internal clinical operations staff and manage the on-boarding and off-boarding of assigned staff.
• Provide strategic direction on field and remote monitoring of studies and data collection for all clinical trials, act as a Core Team lead (as required), assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial documentation is within parameters of study protocol, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
• Lead in the identification and evaluation of alignment opportunities to standardized processes across the organization and lead the implementation of course correction
• Identify and mitigate risks due to multiple competing timeline assessments

Required Education/Skills/Experience:

• Bachelor Degree in related field
• Experience in clinical imaging and/or vendor management
• Hands-on clinical research experience
• Demonstrated track record in people management
• Experience working in a regulated industry is highly preferred
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Proven successful project management skills
• Proven expertise in Microsoft Office Suite, including advanced Excel required
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Excellent problem-solving and critical thinking skills
• Expert understanding of clinical operations procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
• Extensive knowledge of human anatomy and physiology
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Good leadership skills and ability to influence change
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to interact with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control