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:- Creating complex metrics to identify discrepancies and trends in data utilizing clinical systems and reports. Providing recommendations to improve data status during study conduct to the study team and through query management.
- Defining and specifying clinically complex data collection requirements (e.g., eCRFs, edit checks, SDV, and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
- Leading project management activities for multiple (multi-site and multi-cohort) projects to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
- Developing and maintaining Data Management deliverables including data management plans (DMPs) training materials and user aids in compliance with regulations.
- Evaluating data discrepancies and collection issues; providing guidance and recommendations to end users and the clinical team for resolution.
- Leading development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.
What you'll need (Required):- Bachelor's Degree with 5 years of previous related experience in clinical research including clinical data management and/or clinical data entry or equivalent work experience based on Edwards criteria.
- Experience with EDC (Electronic Data Capture) systems or equivalent work experience based on Edwards criteria.
What else we look for (Preferred): - Expertise in Medidata clinical systems
- Proven expertise in Microsoft Office Suite
- Basic project management skills
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
- Excellent problem-solving and critical thinking skills
- Full knowledge and understanding of policies, procedures and guidelines relevant to clinical research
- Full knowledge of processes and procedures in clinical data management
- Full knowledge of protocols, DMPs, and SAPs
- Ability to manage competing priorities in a fast-paced environment
- Strict attention to detail
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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 $108,000 to $153,000 (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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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