Edwards Lifesciences Associate Manager, Clinical Data Standards (Remote US) TMTT in Raleigh, North Carolina
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 candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.
Key Responsibilities include but are not limited to:
Drive data standards implementation by ensuring technical quality compliance in alignment with industry standards (e.g., CDISC) and regulatory guidance, consistency in the adoption of data standards across clinical systems and provide technical guidance for study teams
Provide functional expertise to clinical data standards solutions, and lead the activities clinical data standards solutions to support data collection, reporting, and submission
Lead the maintenance of the clinical standards library components and metadata
Assess the standards utilization to identify and make recommendation to improve gaps, inefficiencies, and deviations in the standards structure and processes by conducting periodic review of performance metrics
Lead in the maintenance, review, and testing of clinical data standards Governance
Participate in cross-functional clinical data standards innovation initiatives and projects
Support the handling and processing clinical data standards related requests and inquiries from other functional teams
Develop and lead the review of SOPs, work instructions, process improvements and associated procedures for clinical data standards
Provide training and guidance to lower-level staff
A minimum of 8 years relevant experience
A minimum of 6 years’ experience working in EDC systems
Proven project management experience from start to completion
Extensive knowledge and understanding of policies, procedures, and guidelines relevant to clinical data standards
Ability to work West Coast hours regularly
Ability to travel up to 25%
Preferred Qualifications: In addition to meeting minimum requirements, it would be nice to have the following:
Working knowledge of Medidata Rave
Previous experience developing clinical standards
Additional Talents and General Expectations:
Proven expertise in Microsoft Office Suite
Proven successful project management skills
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
Extensive knowledge of processes and procedures in clinical data management
Extensive knowledge of relational databases, systems, and programming languages
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
For Colorado Residents Only:
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.
The base pay range for this position is $117,000 to $137,000
Additional information can be found through the link below:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.
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 15,000 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.
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