Senior Clinical Data Manager
1 day ago
Imagine how your 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.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence.
This role can be either an onsite or hybrid role based at Edwards' Irvine campus, or a remote-based role in the U.S.
Key Responsibilities:
- Translate clinical study business requirements into system requirements for collecting and managing data from Clinical trials.
- Ensure the quality and integrity of data collected in Clinical studies, the privacy of patient data, and the efficient recording and reporting of safety-related issues.
- Conduct all clinical data management functions (lead clinical study set-up, migrations, conduct/maintenance to database lock).
- 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.g. test 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.
- Other incidental duties assigned by Leadership.
Requirements:
- Bachelor's degree and 5 years of previous related experience in clinical research including clinical data management and/or clinical data entry
- OR Associate degree or equivalent in a related field and 7 years of previous related experience in clinical research including clinical data management and/or clinical data entry
- AND Experience with EDC (Electronic Data Capture)
Preferred Qualifications:
- Proven expertise in Microsoft Office Suite
- Advanced Excel skills (pivot tables and formulas)
- Microsoft Power BI
- Project management skills
- Lead cross functional meetings
- Experience with Medidata RAVE
- Full knowledge of processes and procedures in clinical data management
- Full knowledge of protocols, DMPs, and SAPs
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills.
- Excellent problem-solving and critical thinking skills
- 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.
What We Offer:
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 $103,000 to $146,000 (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.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
-
Senior Clinical Data Manager
2 weeks ago
Irvine, California, United States Edwards Lifesciences Full timeTransform Patient Care with Edwards LifesciencesImagine how your expertise can change a patient's life. At Edwards Lifesciences, 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...
-
Senior Data Scientist Clinical Analytics
3 weeks ago
Irvine, California, United States Allergan Aesthetics Full timeJob OverviewAbbVie's Clinical Analytics team is seeking a Senior Data Scientist to drive innovation and experimentation in clinical development processes. As a key technical leader, you will leverage advanced analytics techniques to enable data-driven insights for complex business problems across R&D.Key ResponsibilitiesCollaborate with cross-functional...
-
Senior Data Product Manager
3 weeks ago
Irvine, California, United States Motion Recruitment Full timeJob Title: Senior Data Product ManagerWe are seeking a highly skilled Senior Data Product Manager to join our team. As a Senior Data Product Manager, you will be responsible for overseeing the development and delivery of curated datasets, augmented data elements, and an array of data products.Key Responsibilities:Prioritize the development of data products...
-
Senior Data Product Manager
4 days ago
Irvine, California, United States Motion Recruitment Full timeJob Title: Senior Data Product ManagerA leading company in the medical aesthetic industry is seeking a Senior Data Product Manager to oversee the development and delivery of curated datasets, augmented data elements, and data products. The ideal candidate will have a strong understanding of data-oriented roles and experience working in a startup...
-
Senior Data Product Manager
1 day ago
Irvine, California, United States Motion Recruitment Full timeJob Title: Senior Data Product ManagerA leading medical aesthetic company is seeking a Senior Data Product Manager to oversee the development and delivery of curated datasets, augmented data elements, and data products. The ideal candidate will have a strong understanding of data engineering, data science, and machine learning, as well as experience working...
-
Senior Manager, Data Engineering Position
3 weeks ago
Irvine, California, United States Ingram Micro Full timeAbout the RoleIngram Micro is seeking a highly skilled Senior Manager, Data Engineering to lead our data warehousing platform team. As a key member of our IT organization, you will be responsible for designing, implementing, and optimizing our data warehousing infrastructure to support business intelligence and analytics needs.Key ResponsibilitiesDevelop and...
-
Clinical Data Associate
2 weeks ago
Irvine, California, United States Planet Pharma Full timeJob Title: Clinical Data Associate/ReviewerPlanet Pharma is seeking a highly skilled Clinical Data Associate to join their team. This role is responsible for resolving queries and data cleaning/review in a mid-sized medical/biotech company.Key Responsibilities:Create data cleaning strategies and lead data cleaning efforts to support Clinical Studies.Lead and...
-
Clinical Data Associate
4 weeks ago
Irvine, California, United States Planet Pharma Full timeJob Title: Sr. Clinical Data Associate/ReviewerPlanet Pharma is seeking a highly skilled Clinical Data Associate to join their team. This role is responsible for resolving queries and data cleaning/review in a fast-paced medical/biotech environment.Key Responsibilities:Develop and implement data cleaning strategies to ensure high-quality data.Lead regular...
-
Clinical Data Associate
3 weeks ago
Irvine, California, United States Planet Pharma Full timeJob Summary:We are seeking a highly skilled Clinical Data Associate to join our team at Planet Pharma. The successful candidate will be responsible for creating data cleaning strategies, leading data cleaning efforts, and performing regular data review across studies to identify quality issues and generate queries as necessary.Key Responsibilities:Develop...
-
Senior Data Analyst
1 day ago
Irvine, California, United States Resource Informatics Group Full timeJob Title: Senior Data AnalystJoin our team at Resource Informatics Group as a Senior Data Analyst and take on a challenging role that requires expertise in data analysis, business intelligence, and data management.Key Responsibilities:Collaborate with business analysts to design dimensional models and source-to-target ETL specifications.Analyze and...
-
Senior Data Scientist
4 weeks ago
Irvine, California, United States Finfare Full timeJob Title: Senior Data ScientistAbout FinfareFinfare is a leading provider of expense management solutions for growing businesses. Our mission is to empower SMBs by streamlining their financial operations and maximizing cash back rewards.Job SummaryWe are seeking a highly skilled Senior Data Scientist to join our team. As a key member of our data-driven...
-
Senior Clinical Trial Management Associate
4 days ago
Irvine, California, United States PSG Global Solutions Careers Full timeUnlock Your Potential in Clinical ResearchPSG Global Solutions Careers is seeking a highly skilled Senior Clinical Trial Management Associate to join our team.About the RoleWe are looking for a seasoned professional to assist in the operational execution of assigned clinical studies. As a Senior Clinical Trial Management Associate, you will work closely with...
-
Senior Clinical Research Specialist
1 day ago
Irvine, California, United States Kelly Science, Engineering, Technology & Telecom Full timeJob SummaryWe are seeking a highly skilled Senior Clinical Research Specialist to join our team at Kelly Science, Engineering, Technology & Telecom. As a key member of our Clinical R&D Department, you will play a critical role in supporting the execution of company-sponsored clinical trials, ensuring compliance with timelines and study milestones.Key...
-
Irvine, California, United States Amazon Full timeAbout the RoleThe Senior Data Scientist within Ring Data Science and Engineering plays a pivotal role in shaping how we carry the voice of our customers.We strive to understand their behaviors and preferences in order to provide them with the best experience connecting with the places, people and things that matter to them.This role will build scalable...
-
Clinical Research Coordinator
2 weeks ago
Irvine, California, United States Irvine Clinical Research Full timeAbout Irvine Clinical ResearchIrvine Clinical Research is a leading independent memory research center on the West Coast, dedicated to advancing the fight against Alzheimer's Disease.Job SummaryWe are seeking a friendly and outgoing Clinical Research Recruitment Coordinator to join our team. As a key member of our recruitment team, you will play a vital role...
-
Clinical Research Coordinator
4 days ago
Irvine, California, United States Irvine Clinical Research Full timeAbout Irvine Clinical ResearchIrvine Clinical Research is a leading independent memory research center on the West Coast, dedicated to advancing the fight against Alzheimer's Disease.Job SummaryWe are seeking a highly motivated and compassionate Clinical Research Recruitment Coordinator to join our team. As a key member of our recruitment team, you will play...
-
Senior Marketing Manager, Evidence Marketing
3 weeks ago
Irvine, California, United States J&J Family of Companies Full timeJob Title: Senior Marketing Manager, Evidence MarketingJohnson & Johnson is seeking a highly skilled Senior Marketing Manager to lead the development and execution of marketing strategies for our electrophysiology business. The successful candidate will be responsible for creating and implementing multi-channel marketing campaigns that effectively...
-
Financial Operations Manager
5 days ago
Irvine, California, United States Irvine Clinical Research Full timeController Job DescriptionIrvine Clinical Research is a leading clinical research company on the West Coast, with a strong presence in neurology, psychiatry, and obesity medicine. Our company is at the forefront of Alzheimer's Disease prevention and treatment drug trials, and our doctors have made significant contributions to the most recently FDA-approved...
-
Senior Big Data Engineer
4 days ago
Irvine, California, United States ASCENDING Full timeJob OverviewWe are seeking a highly skilled Senior Big Data Engineer to join our team at ASCENDING. As a key member of our Quality Assurance department, you will be responsible for designing and implementing data pipelines using Spark and AWS. Your expertise in data engineering and ETL processes will be crucial in ensuring the smooth operation of our Big...
-
Senior Clinical Research Coordinator
5 days ago
Irvine, California, United States Johnson & Johnson Full timeJob SummaryWe are seeking a highly skilled Clinical Research Specialist to play a critical role in the design, execution, and management of clinical research studies. The ideal candidate will have a strong background in clinical research, excellent project management skills, and the ability to work effectively in a fast-paced environment.Key...