Senior Manager, Safety and Scientific Content
Senior Manager, Safety and Scientific Content-008869
- Responsible for developing scientific content from pre and post commercial global clinical trials/registries on Edwards Lifesciences products to ensure relevant external and internal communication in compliance with health authorities and Regulatory agencies requirements
- Management of Safety Officers and Safety CRAs.
- Initiate, develop and maintain liaison among physicians/investigators, other medical professionals, Research Organizations (CRO's), hospitals and research institutions to manage clinical trials/Registries and exploit their results for communication, approval and reimbursement purposes.
- Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and reports/data presentations/publications. Oversee clinical data collection, trial monitoring and auditing according to GCP guidelines and Edwards Global Policies and Standard Operating Procedures
Major Job Functions:
- Centralizing internal expertise surrounding our products and generated clinical data
- Developing privileged links with the scientific community with a view of optimal exploitation of our data
- Coordinating processes of data generation and communication
- Ensuring quality compliance of safety related activities
- Maintaining appropriate regulatory documents both internally and externally;
- Managing Safety Officers and Monitors
- Managing and developing direct reports;
- Managing projects, processes, preparation and dissemination of study data and study reports, internal and external relationships, and Consultants.
Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas required. Must have previous managerial experience of clinical projects and people.
An MD degree or bachelor's degree in a scientific or related discipline required with a minimum of eight years for. An advanced degree in a related discipline and/or Professional Health Science certification or designation preferred.
- Requires a broad cross-disciplinary and in-depth knowledge of the clinical profession;
- Requires a broad cross-functional team experience;
- A qualified record of implementing new clinical projects;
- Comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills;
- Ability to meet deadlines on multiple projects required;
- Must be able to perform in a diverse cross-functional team environment and have ability to converse effectively with all levels of employees, management, and customers;
- A comprehensive record of delivering research information which adds value to management decision making process;
- A demonstrated ability to understand and comply with all current applicable regulations including), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 14155, Good Clinical Practice(GCP) and Company operating procedures, processes, policies, and tasks;
- Professional conduct and appearance;
- Advanced personal computer skills including spreadsheet, word processing, database management, power point and other necessary applications preferred.
- Ability to manage multiple tasks and projects simultaneously
- Ensure clear communication in diplomatic manner, understanding pan European cultural differences
- Familiarize with Edwards environment, processes & products
- Work autonomously
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 8,200 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Job Function: Clinical Affairs
Primary Location: Europe, Middle East, Africa, Canada (EMEAC)-Switzerland