Job description

Edwards has an exciting opportunity with our Surgical Structural Heart group, focused on transforming patients' lives by advancing surgical structural heart innovations.

The Sr. Manager, Clinical Data Management is responsible for managing and conducting data-related activities for multiple clinical trials to ensure data availability, quality, accuracy, and compliance. The incumbent will provide subject matter expertise and lead all aspects of clinical data management for assigned concurrent projects from clinical study start-up to conduct and study closeout.

Position location: Onsite - Irvine, California (open to Hybrid)

Key Responsibilities:
Define and lead data management activities for multiple complex projects to deliver high quality data and meet the study milestone.

Define, develop and/or review creation of essential Data Management deliverables including data management plans (DMPs), data transfer specifications, eCRF Completion Guidelines, training materials, and user aids, etc.

Oversee the data monitoring/cleaning activities according to DMP (Data Management Plan), SOPs and regulatory requirements

Ensure compliance of clinical data management process with applicable regulatory requirements

Provide functional expertise and oversee the activities for complex collection data requirements and/or testing (e.g., eCRFs, CRFs, edit checks and collection of external data)

Review, create, maintain, and implement SOPs, work instructions, and other process-related documentation. Organize and lead cross-functional team for process improvement initiatives, best practice, lesson learned and other general workflow optimization with respect to data management function to ensure compliance, accuracy, and efficiency across functional areas.

Identify complex issues related to data management process and propose solutions to improve team’s effectiveness and efficiency

Identify and make recommendations on trends in data discrepancies and remediation, including developing instruments (e.g., query reports, data review meetings), and training requirements across studies and therapeutic areas to ensure uniformity in approach and execution.

Manage CDM related requests from external stakeholders (e.g., regulators, notified bodies, non-governmental agencies, core labs, independent study committee, and auditors)

Act as a consultant in data management processes and principles for all projects and other functional groups

Collaborate with vendors and internal teams to define and develop integration (data & process) specifications for clinical trial database.

Other duties as assigned by leadership

Required Qualifications

Bachelor's Degree in related field, 10 years of previous related experience in clinical research including clinical data management required;

or Master's Degree or equivalent in related field, 8 years of previous related experience in clinical research including clinical data management required

Experience with EDC (Electronic Data Capture) systems and software testing in a clinical research or clinical data management environment

Experience in cross-functional query report resolution

Experience authoring DMPs, SOPs, and training materials

Understanding of general knowledge of industry practices and standards such as ICH GCP and regulatory requirements for clinical data systems including 21 CFR Part 11

Preferred Qualifications

Master's degree

Medidata Rave is strongly preferred

Additional Skills:
Proven successful project management skills

Proven expertise in Microsoft Office Suite and related tools and systems

Additional clinical, statistical software, programming language, and tools, such as SQL, JavaScript, SAS, Python, are highly desired

Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

Recognized as an expert in own area with specialized depth within the organization

Expert knowledge and understanding of processes and procedures in clinical data management

Expert knowledge and understanding of protocols, DMPs, and SAPs

Expert understanding of regulatory policies as it relates to CDM processes

Strict attention to detail

Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

Ability to manage competing priorities in a fast paced environment

Represents leadership on projects within a specific area interfacing with project managers and clinical data management team

Consult in project setting within specific clinical data management area

Provides leadership to outsourcing partners on a task level, and may participate on small scale RFP

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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 $128,000 to $181,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

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 13,000 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.

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.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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