Principal, Clinical Programming, Surgical

Edwards Lifesciences Gruppe; Irvine (CA); Hybrid; USD 132,000 - 186,000; Full time

Job summary

Edwards Lifesciences is seeking an experienced Clinical Programmer to join the Clinical Affairs team in California. You will provide technical expertise in clinical programming, lead database and tool development, and collaborate with investigators and regulatory bodies to optimize trial data management.

Ideal candidates have 6+ years in clinical research or data management, strong Medidata experience, and proficiency in C# and SQL.

Qualifications

• Bachelor's Degree in a related field; minimum 6 years in clinical research, data management, software programming or related.
• Extensive experience with EDC (Medidata) programming.
• Strong knowledge of Medidata custom functions in C# or SQL.

Responsibilities

• Provide technical expertise in clinical programming and lead development of clinical databases and tools for data validation and trial reporting.
• Lead cross functional teams in design and delivery of complex modules and specifications for systems/processes.
• Develop and present high level technical training for end-users and junior programmers.
• Identify resource needs for database implementation and participate in evaluation of external resources/vendors.
• Manage daily activities of outsourced systems and services used in clinical trials.
• Contribute to creation/revision of SOPs, workflows, forms and templates to ensure regulatory compliance.

Skills

Medidata programming

C#

SQL

EDC systems

Data validation

Microsoft Office

Education

Bachelor's Degree in a related field

Master's Degree or PhD (preferred)

Tools

Medidata

Relational databases

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 stakeholdersLead cross functional teams in the design and delivery of complex functional modules and provide clinical programming expertise regarding clinical trials, protocols, and case report formsLead the development of specifications for systems and/or processes, system upgrades/enhancements and integration; and engage IT to deliver higher level support to usersDevelop and present high level technical training to end-users, including providing guidance to lower-level Clinical Programmers in their training program developmentIdentify resource needs for database implementation and participate in the evaluation of external resources/vendorsManage daily service providers’ activities for outsourced systems and services used in clinical trialsParticipate 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 requirementsWhat 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 criteriaExtensive experience with EDC (Electronic Data Capture) systems; Medidata programming experienceWhat 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 criteriaExpert knowledge in creating new and maintaining existing Medidata custom functions in C# or SQL.Proven successful project management skillsProven expertise in both Microsoft Office Suite, including advanced Excel and CDM (Clinical Data Management) systemsExcellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectivesGood presentation and facilitation skillsAbility to translate technical information to cross-functional teamsExtensive 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 databasesExtensive knowledge of processes and procedures in clinical data managementExtensive knowledge of relational databases, systems, and programming languagesExtensive knowledge of clinical programming as it relates to business processesAbility to manage competing priorities in a fast-paced environmentRepresents leadership on sections of projects within a specific area interfacing with project managers and team membersAligning 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). Applications will be accepted while this position is posted on our Careers website.#LI-HybridEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.