Edwards Lifesciences Corp Irvine , CA 92606
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.
The Senior Clinical Data Manager (internally titled as Sr. Analyst, Clinical Data) will translate clinical study business requirements into system requirements for the collection and management of data from clinical trials. The Analyst will 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.
Identify and make recommendations on trends in data discrepancies and remediation, e.g., developing instruments to effectively identify trends in data discrepancies, identifying need for training and recommending appropriate training programs.
Lead project management activities for multiple complex (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.
Define and specify clinically complex data collection requirements (such as eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating testing of data collection instruments (e.g. test scripts and checklists) to ensure appropriate data are collected.
Develop Data Management deliverables including data management plans (DMPs), training materials and user aids.
Review and clean data according to DMP (Data Management Plan), SOPs and associated documents using the clinical data management system, listings, and reports.
Perform Site/User Administration, developing Electronic Data Capture (EDC) applications for user completion 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.
Required Education and skills:
Bachelor's degree preferred preferably in life sciences.
Minimum five years' experience in clinical research required.
Minimum of three years' experience in Clinical Data Management (CDM) supporting medical device, pharmaceutical, or biotechnology required.
3 years' Experience with EDC (Electronic Data Capture) systems required.
Excellent written and verbal communication skills, analytical skills, strong organizational skills, self-motivated, flexibility and adaptability.
Ability to understand protocols, DMPs, SAPs, and to collaborate effectively with the Clinical study teams.
Basic project management skills.
Excellent problem-solving and critical thinking skills.