Principal, Clinical Programming, Surgical

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.

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives.

Join us and be part of our inspiring journey.

• Provide technical expertise in clinical programming functional area and lead in the development of clinical databases, and tools and programs for data validation checks, and clinical trial reporting in collaboration with key stakeholders
• Lead cross functional teams in the design and delivery of complex functional modules and provide clinical programming expertise regarding clinical trials, protocols, and case report forms
• Lead the development of specifications for systems and/or processes, system upgrades/enhancements and integration; and engage IT to deliver higher level support to users
• Develop and present high level technical training to end-users, including providing guidance to lower-level Clinical Programmers in their training program development
• Identify resource needs for database implementation and participate in the evaluation of external resources/vendors
• Manage daily service providers’ activities for outsourced systems and services used in clinical trials
• Participate in the creation and revision of new or existing SOPs, work instructions, workflow, forms, and templates to ensure clinical systems and activities are in compliance with the regulatory and company requirements

• Bachelor's Degree and a minimum of 6 years experience in clinical research, data management, software programming or related field or equivalent work experience based on Edwards criteria
• Extensive experience with EDC (Electronic Data Capture) systems;
  Medidata programming experience

• Master's Degree and a minimum of 5 years experience in clinical research, data management, software programming or related field or equivalent work experience based on Edwards criteria
• a Ph.D. and a minimum of 2 years experience in clinical research, data management, software programming or related field or equivalent work experience based on Edwards criteria
• Expert knowledge in creating new and maintaining existing Medidata custom functions in C# or SQL.
• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel and CDM (Clinical Data Management) systems
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Good presentation and facilitation skills
• Ability to translate technical information to cross-functional teams
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive knowledge and understanding of policies, procedures and…