Principal, Clinical Programming, Surgical

Regulatory Toolkit; Irvine (CA); Hybrid; USD 132,000 - 186,000; Full time

Job summary

Edwards is seeking a seasoned Clinical Programmer to join our Clinical Affairs team in California. You will lead the development of clinical databases, data validation checks, and trial reporting, collaborating with investigators, medical professionals, patient advocates, and regulatory authorities to advance our innovative therapies.

The role requires a Bachelor's degree and 6+ years in clinical research or related fields, with extensive Medidata/EDC experience.

Qualifications

• Bachelor's Degree and minimum 6 years in clinical research or related field.
• Extensive experience with EDC systems; Medidata programming experience.
• Master's Degree with 5+ years or PhD with 2+ years preferred.
• Expert knowledge in creating new Medidata custom functions in C# or SQL.

Responsibilities

• Provide clinical programming in data validation checks and trial reporting in collaboration with key stakeholders.
• Lead cross functional teams in design and delivery of complex functional modules and provide clinical programming expertise regarding trials, protocols, and CRFs.
• Lead the development of specifications for systems and/or processes, system upgrades/enhancements and integration; engage IT to deliver higher level support.
• Develop and present high level technical training to end-users, including guidance to junior Clinical Programmers.
• Identify resource needs for database implementation and evaluate external resources/vendors.
• Manage daily service providers' activities for outsourced systems and services used in clinical trials.
• Participate in the creation and revision of SOPs, work instructions, workflow, forms, and templates to ensure compliance.

Skills

Clinical programming

Data management

Project management

Communication skills

Presentation skills

Interpersonal relationships

Education

Bachelor's Degree

Master's Degree

PhD

Tools

Medidata

SQL

Microsoft Excel

CDM systems

Job description

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.

How you will make an impact:

• 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

What you will need (Required):

• 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

What else we look for (Preferred)

• 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 OR 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 guidelines relevant in the development of clinical databases
• Extensive knowledge of processes and procedures in clinical data management
• Extensive knowledge of relational databases, systems, and programming languages
• Extensive knowledge of clinical programming as it relates to business processes
• 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 team members

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $132,000 - $186,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

#LI-Hybrid

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.