Senior Clinical Data Manager - Edwards Lifesciences
Irvine, CA
About the Job
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.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
As the Senior Clinical Data Manager , you will 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. As well as conduct all clinical data management functions (lead clinical study set-up, migrations, conduct/maintenance to database lock).
This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.
How you will make an impact:
+ 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
What you'll need (Required):
+ 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
+ Experience with Medidata Rave EDC (Electronic Data Capture)
What else we look for (Preferred):
+ Minimum of 2 years leading clinical studies combined with 5 years of relevant experience in clinical research, including roles in clinical data management and/or clinical data entry.
+ Full knowledge of protocols, DMPs, SAPs, Database Specification, and Data Validation Specification
+ Proven expertise in Microsoft Office Suite
+ Advanced Excel skills (pivot tables and formulas)
+ Microsoft Power BI
+ Project management skills and lead cross functional meetings
+ Full knowledge of processes and procedures in clinical data management
+ 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.
For California, the base pay range for this position is $103,000 to $140,000 (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.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
As the Senior Clinical Data Manager , you will 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. As well as conduct all clinical data management functions (lead clinical study set-up, migrations, conduct/maintenance to database lock).
This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.
How you will make an impact:
+ 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
What you'll need (Required):
+ 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
+ Experience with Medidata Rave EDC (Electronic Data Capture)
What else we look for (Preferred):
+ Minimum of 2 years leading clinical studies combined with 5 years of relevant experience in clinical research, including roles in clinical data management and/or clinical data entry.
+ Full knowledge of protocols, DMPs, SAPs, Database Specification, and Data Validation Specification
+ Proven expertise in Microsoft Office Suite
+ Advanced Excel skills (pivot tables and formulas)
+ Microsoft Power BI
+ Project management skills and lead cross functional meetings
+ Full knowledge of processes and procedures in clinical data management
+ 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.
For California, the base pay range for this position is $103,000 to $140,000 (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.
Source : Edwards Lifesciences