Senior Manager, Clinical Data Analytics

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 139,000 - 196,000; Full time

Job summary

Edwards Lifesciences invites a seasoned Clinical Safety Analytics leader to own end-to-end design, validation, and maintenance of safety dashboards for internal governance bodies. You will drive data reconciliation across clinical safety databases and ensure timely regulatory reporting.

You will mentor a growing team, partner with Biostatistics, Clinical Data Management, and Engineering, and translate safety requirements into scalable technical specifications for cloud-based dashboards.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Demonstrated track record in people management and leadership.
• Experience in clinical safety/pharmacovigilance and regulatory aspects of medical devices is preferred.

Responsibilities

• Own end-to-end design, validation, and maintenance of clinical safety dashboards and reports for governance bodies.
• Lead safety data reconciliation across clinical databases, safety databases, and central lab/vendor sources.
• Ensure regulatory-compliant expedited/periodic safety reporting in partnership with PV/Regulatory.
• Manage a team responsible for safety data QC, dashboard build/maintenance, and ad hoc analytics.
• Partner with Biostatistics, Clinical Data Management, and Medical Safety on signal detection and dashboard logic.
• Collaborate with cloud/data engineering to translate needs into technical specs and data models.
• Develop and deliver presentations on clinical operations and study developments to stakeholders.
• Identify issues, drive root-cause resolution, and implement process improvements.

Skills

People management

Leadership

Project management

Data analysis

Python (pandas/NumPy)

BI tools

Communication

Education

Bachelor's Degree

Job description

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’ll make an impact:Own end-to-end design, validation, and maintenance of clinical safety dashboards and reports (AE/SAE trends, coding accuracy, reporting timeliness) for internal stakeholders and safety governance bodies (e.g., DSMB, Safety Review Committee)Lead safety data reconciliation across clinical database, safety database, and central lab/vendor sourcesEnsure regulatory-compliant and timely expedited/periodic safety reporting (e.g., DSURs, IND safety reports) in partnership with Pharmacovigilance/RegulatoryManage a team responsible for safety data QC, dashboard build/maintenance, and ad hoc safety analytics requestsPartner with Biostatistics, Clinical Data Management, and Medical Safety on signal detection methodology and dashboard logicPartner with cloud/data engineering teams to translate clinical/safety reporting needs into technical requirements (data model, refresh cadence, query performance) for dashboard consumptionDevelop a robust talent development plan in alignment with functional growth strategies of the departmentDevelop and deliver comprehensive presentations and written communications on clinical operations and study developments to stakeholders and managementIdentify issues and collaborate with appropriate team members to bring to resolution; determine root cause; recommend and lead the implementation of corrective actions, complex process development and process improvement solutions to optimize strategic imperativesWhat you’ll need (Required):Bachelor's Degree or equivalent in a related field, or equivalent work experience based on Edwards criteriaDemonstrated track record in people management, or equivalent work experience based on Edwards criteriaWhat else we look for (Preferred):Experience in clinical safety/pharmacovigilance and regulatory aspects of medical device technology, or equivalent work experience based on Edwards criteria —Proven successful project management and leadership skills with the ability to influence changeDemonstrated strong problem-solving, process improvement, analytical, and collaborative skillsExcellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectivesExpert understanding of forecasting, reporting and analytics while addressing issues with impact beyond own team based on knowledge of related disciplinesExpert understanding of related aspects of processes and/or systemsProficiency in Python (e.g., pandas, NumPy) for clinical/safety data analysis, validation, and QC, with working knowledge of web app frameworks (e.g., Flask, Streamlit, Dash) used to build or extend the safety dashboard applicationExperience with a validated clinical/safety database and dashboarding/BI tools (e.g., Tableau, Power BI, Spotfire)Familiarity with MedDRA/WHO-DD coding conventions and working knowledge of ICH-GCP safety reporting requirementsWorking knowledge of cloud-hosted data architectures (AWS preferred) and data lake concepts (ingestion, ETL/ELT, data cataloging) sufficient to partner effectively with engineering teams — not expected to build pipelines personally, but must be able to translate business/safety requirements into technical specs and validate outputsProven expertise in MS Office Suite, SharePoint, and ability to operate general office machineryStrict attention to detailAbility to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organizationAbility to work and excel within a fast-paced, dynamic, and constantly changing work environmentAbility to frequently interact with customers and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project teamAdhere 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/controlAligning 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 (CA), the base pay range for this position is $139,000 to $196,000 (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.