Job details
Salary $117,000 - $137,000 a year job type full-time
Full job description
This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting edge technologyThe transcatheter heart valve (thv) team extends edwards’s leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other options, eventually positioning thv as the treatment of choice for aortic stenosisIn addition, this is also an opportunity to work on programs that are dedicated to innovating the future and developing new technologies based on identified needs in structural heart disease to transform treatment & significantly improve patients’ lives.
The staff clinical data manager will work together with a group of highly motivated clinical research experts in order to translate clinical study business requirements into actionable data that will be used as evidence to support our regulatory submissions and bring products to the marketAll ensuring the quality and integrity of data collected, the privacy of patient data and efficient recording and reporting of safety related issues for their assigned clinical studies.
** **this position is either located in our irvine, ca office or remote anywhere in the usa**
Key responsibilities including but not limited to:
Create complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide recommendations to improve data status during study conduct
Define and specify clinically complex data collection requirements (e.g., ecrfs, crfs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.gTest scripts and checklists) to ensure appropriate data are collected
Lead 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
Develop and maintain data management deliverables including data management plans (dmps), training materials and user aids in compliance with regulations
Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution
Perform site/user administration to allow access to the database, ensuring all users are qualified to access data base; may provide guidance on more complex access rights for users
Lead 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
Required qualifications:
Bachelor’s degree
A minimum of 8 years’ experience in clinical data management in the medical device, pharmaceutical, or biotechnology industry
Ability to understand protocols, data management plans (dmps), and statistical analysis plans (saps) and to collaborate effectively with the clinical study teams
Knowledge and understanding of policies, procedures, and guidelines relevant to clinical research
Knowledge of processes and procedures in clinical data management
Ability to travel up to 25%
Preferred qualifications:
Experience with medidata rave edc (electronic data capture) system
Experience in interventional cardiology clinical studies from inception to pma submission
Ability to bring a meaningful difference to the treatments we develop
Excellent written and verbal communication skills, analytical skills, strong organizational skills, self-motivated, flexibility and adaptability
Proficient in microsoft office suite
Basic project management skills
Excellent problem-solving and critical thinking skills
Ability to manage competing priorities in a fast-paced environment
Strict attention to detail
Must be able to work in matrix organizations, representing both your functional and the study teams on specific projects
Ability to build productive internal/external working relationships
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:
Https://www.edwards.com/careers/benefits
E dwards 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 worldAs such, all patient-facing and in-hospitals positions require covid-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their roleIf 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.
