Senior Manager, Clinical Data Management

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Data management position is a unique career opportunity that could be your next step towards an exciting future.

Responsible for clinical data management (CDM) strategy, execution, and staffing for multiple clinical trials within the trans catheter heart valve (THV) business unit within a region. Is knowledgeable regarding regulatory policies and applies this knowledge to CDM processes. Ensures CDM deliverables are of high quality and are provided in a manner to support the overall Clinical Strategy.

How you will make an impact:

• •Manage a small team of clinical data management SMEs to maintain project assignments, set goals and expectations, and provide issue resolution support to direct reports.
• •Plan and lead Data Management activities for multiple (multi-site and multi-cohort) projects for both clinical trials and PMS (Post Monitoring Surveillance) post commercial trials, with accountability for successful completion to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
• •Develop Data Management deliverables including data management plans (DMPs), SOPs, work instructions, user training and associated documents for CDM.
• •Identify and evaluate Data Management process improvements and course correction/course alignment opportunities (e.g., developing instruments to effectively identify trends in data discrepancies, identifying need for training and recommending appropriate training programs.)
• •Provide direction and guidance to other team members (e.g. CRAs, PMS staff) to execute tactical Data Management initiatives
• •Identify discrepancies in data and investigate and liaise with Doctors and clinicians to develop solutions to resolve issues
• •Other incidental duties

• Education and Experience:
• Bachelor's Degree in in related field , 8 years years experience in Clinical Data Management (CDM), clinical data entry, or clinical research Required and
• Experience working with clinical data and systems Required

• What you’ll need (Required):
• •Proven successful project management skills
• •Proven expertise in both Microsoft Office Suite (including advanced Excel) and EDC (Electronic Data Capture) systems
• •Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• •Good English skills
• •Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• •Extensive understanding of related aspects of Clinical Data Management processes and/or systems
• •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 manage competing priorities in a fast paced environment
• •Represents leadership on sections of projects within a specific area interfacing with project managers and Clinical Affairs team
• •Consult in project setting within specific sections of Clinical Data Management area
• •Provides Clinical Data Management leadership to outsourcing partners on a task level
• •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