Edwards Lifesciences Senior Manager, Clinical Programming – Transcatheter Mitral & Tricuspid Therapies in Irvine, California
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease.
The Senior Manager, Clinical Programming will be accountable for the overall success of the Clinical Programming team. The ideal candidate is a dynamic, driven and decisive data management professional who thrives in a fast paced and growing environment. This individual will represent all aspects of the Clinical Programming function through the clinical development process, and will advise on the conduct of clinical studies, database development, and data quality assurance including creation of SOPs and work guidelines as required.
Essential Job Functions/Key Responsibilities:
Manage a team of managers and/or clinical data management SMEs at all professional levels with a responsibility for talent development to ensure the alignment with functional growth strategies of the department
Oversee all aspects of clinical system programming for all concurrent projects from clinical study start-up to conduct and study closeout. Act as the technical leader in clinical system functions, programming methodology, and related functional processes and principles for all project teams and other functional groups. Be the key contact point for all clinical programming interactions with leadership across functions to set, communicate and discuss expectations and plans
Identify operational issues and risks for concurrent and future projects, and provide solutions/guidance to direct reports and/or project teams through the use of available data, tools, feedback and discussions
Plan and develop resource assignments and operational milestones for all concurrent and future clinical study projects and activities with accountability for successful completion for all direct reports
Monitor general progress to ensure clinical programming milestones and deliverables are met with quality for all concurrent projects
Lead all operational aspects of vendor management, including developing requests for proposal and work orders, establishing resource planning and milestones, reviewing and addressing vendor performance issues, setting and monitoring vendor budget, etc.
Lead the review, creation, and enforcement of SOPs, processes, standards, and work instructions with respect to clinical programming function to ensure compliance, accuracy, efficiency, and optimization
Make resource planning and budgetary recommendations on operational expenditure planning and other financial activities
Review and provide feedback on clinical protocols to ensure sufficient data collection to support study purposes and endpoints
Bachelor's Degree in related field with 12 years or Master's degree in related field with 10 years of previous related experience in clinical research including clinical data management required; Master's degree in related field preferred.
This individual needs to be proficient with RAVE database programming including complex custom function programming.
Experience with EDC (Electronic Data Capture) systems and software testing in a clinical research or clinical data management environment required.
Demonstrated ability to directly manage a team, provide coaching and feedback, including partnering with HR on all aspects of employee relations
Experience authoring DMPs, SOPs, and training materials.
Proven successful project management leadership skills
Proven expertise in Microsoft Office Suite and related tools and systems
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Promote a culture of collaboration and teamwork
Expert understanding of clinical programming procedures while identifying applications of functional knowledge and existing methodologies to complex problems
In-depth therapeutic and business knowledge
Expert understanding of related aspects of clinical programming processes and/or systems
Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical programming to the business
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 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.