Clinical Data Management Analyst

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 Clinical Data Management Analyst, you will translate clinical study business requirements into system requirements for the collection and management of data from clinical trials. Ensure the quality and integrity of data collected in clinical studies, the privacy of patient data and efficient recording and reporting of safety related issues. The successful candidate will 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 moderately complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide basic recommendations to improve data status during study conduct.

• Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution.

• Define and specify clinically 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 a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing, and maintaining project timelines, and communications to stakeholders.

• Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations.

• Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base.

• Participate in 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 duties as assigned by leadership

What you'll need (Required):

• Bachelor's Degree in related field with 3 years’ of previous related work experience in clinical data management including clinical research and/or clinical study data entry OR equivalent work experience based on Edwards criteria

• Experience with EDC (Electronic Data Capture) systems

What else we look for (Preferred):

• Full knowledge of processes and procedures in clinical data management

• Full knowledge of protocols, DMPs, and SAPs

• Medidata RAVE

• Ability to manage competing priorities in a fast-paced environment

• Proven expertise in Microsoft Office Suite (Advanced in Excel)

• 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

• 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