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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 Medical 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.
How you will make an impact:
The Analyst, Clinical Data Management (TMTT) 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).
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.
What you'll need (Required):
Bachelor's Degree 3 years’ experience of previous related experience in clinical data management including clinical research and/or clinical data entry or
Associate degree or equivalent in in related field, 7 years’ experience of previous experience.
Experience with EDC (Electronic Data Capture) systems (Medidata Rave).
What else we look for (Preferred):
Full knowledge of processes and procedures in clinical data management.
Full knowledge of protocols, DMPs, and SAPs.
Ability to manage competing priorities in a fast-paced environment.
Proven expertise in Microsoft Office Suite.
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, 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 $83,000 to $117,000 (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 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 world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.