- Lead clinical operation projects including quarterly audits, annual vendor reviews, etc. to support clinical studies and business initiatives
- Oversee device management activities to ensure devices are shipped in a timely fashion for every case
- Oversee trial training documents to ensure that we're aligned with training matrix(es) and company SOPs
- Monitors for the overall completeness and inspection readiness of the clinical trial master files
- Provide guidance, mentorship and oversight to more junior clinical operations staff members
- Manage the timely execution of key study milestones through management of performance metrics, to ensure effectiveness, LMS compliance, and TMF quality
- Plan, oversee, and lead in the development of procedures and supportive training materials (e.g., work instructions, forms, templates and operational processes) that implement clinical process improvement
- Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues in collaboration with cross functional and/or matrix teams
- Facilitate the creation of training materials related to the planning and conduct of the trial for the internal research team. Conduct training for internal staff and coordinate and present at department team meetings
- Bachelor's Degree in related field PLUS 8 years of relevant clinical trial operations/clinical research/clinical monitoring experience
- Experience working in the medical device industry
- 1-2 years of project management leadership experience
- Proven expertise in Microsoft Office Suite and related clinical tools and systems (e.g., Veeva, CTMS, RAVE)
- Extensive understanding of clinical studies procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline
- Excellent written and verbal communications skills, including negotiating and relationship management skills
- Excellent interpersonal skills
- Excellent critical thinking and problem solving skills
- Ability to travel up to 15%
- Ability to work on-site 4 days and 1 WFH day/week
- Covid-19 vaccination
-
Operations Manager
3 weeks ago
Infosys BPM Irvine, United StatesInfosys BPM is seeking to hire a full time Operations Manager, experienced in Financial Services and Capital Markets in area of Reconciliation to carry out the onsite production activities. · Responsibilities · Reviews, approves, and may prepare, information/entries and supportin ...
-
Operations Project Manager
1 week ago
Insight Global Irvine, United StatesA client in Irvine, CA is looking for an Operations Project Manager to work onsite in Irvine, CA 2 days/week. We are looking for someone who comes from a retail/restaurant industry and has worked in the field and with operations teams. This person will be ensuring project is runn ...
-
Manager, Finance Operations
1 day ago
City of Hope Irvine, United States Full timeJoin the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care lo ...
-
Operations Manager
4 weeks ago
Iwatani Corporation of America Irvine, United StatesJob Summary: · As an Operations Manager for hydrogen fueling stations, you will be responsible for the overall management and operations of our hydrogen fueling stations located throughout Southern and Northern California. Your primary objective will be to ensure efficient and sa ...
-
Operations Manager
4 days ago
Marriott Irvine, United StatesAdditional Information Full-Time · Job Number · Job Category Rooms & Guest Services Operations · Location Residence Inn Irvine John Wayne Airport/Orange County, 2855 Main Street, Irvine, California, United States VIEW ON MAP · Schedule Full-Time · Located Remotely? N · Relocatio ...
-
Operations Manager
4 days ago
Sweeping Corporation of America Irvine, United StatesSCA IS GROWING COME AND GROW WITH US · Our dedicated industry experts have the experience and know-how to get the job done right. While our sole focus is sweeping, our difference is caring. · WHO IS SCA? · Sweeping Corporation of America (SCA) is the largest, self-performing p ...
-
Operations Manager
1 week ago
Compass Group USA Irvine, United StatesOperations ManagerClick Here to Apply OnlineJob Description Bon Appetit Position Title: Operations Manager Salary: 85,000-95,000 Our Passion is FoodAt Bon Appetit Management Company we are committed to two things, great food and outstanding service At Bon Appetit you won't find o ...
-
Operations Manager
1 week ago
Sweeping Corporation of America Irvine, United StatesSCA IS GROWING COME AND GROW WITH US · Our dedicated industry experts have the experience and know-how to get the job done right. While our sole focus is sweeping, our difference is caring. · WHO IS SCA? · Sweeping Corporation of America (SCA) is the largest, self-performing p ...
-
Operations Manager
1 week ago
Infosys BPM Irvine, United StatesInfosys BPM is seeking to hire a full time Operations Manager, experienced in Financial Services and Capital Markets in area of Reconciliation to carry out the onsite production activities. · Responsibilities · Reviews, approves, and may prepare, information/entries and support ...
-
Operations Manager
3 weeks ago
Remake Business Advisors, LLC Irvine, United StatesOPERATIONS MANAGER - needed by Remake Business Advisors, LLC, send only resume to 6 Venture , Irvine CA 92618 ...
-
Manager, Statistical Programming Operations
3 weeks ago
AbbVie Irvine, United States Full timeJob Description · AbbVie Data and Statistical Sciences (DSS) is the best-in-class organization within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical data. Our operational model is exe ...
-
DOM Finance Operations Manager
3 weeks ago
University of California Irvine, United States Full timeRequired Qualifications · Job Opening ID: 66134 Reports To: Chief Financial Officer Working Title: DOM FINANCE OPERATIONS MANAGER Department: DOM Administration Bargaining Unit: 99 FLSA: Exempt Payroll Job Code: Job Location: UCI Campus- Irvine Percent of Time: 100% Work Schedul ...
-
Operations Manager
2 weeks ago
Horizon Dynamics New Richland, United StatesThe transportation industry is the backbone of modern society. Can you imagine using your expertise to create sustainable transportation solutions for the future? If you want to make a global impact by working with cutting-edge technology and the best teams, then you could be a p ...
-
Sr. Manager of Operations
1 week ago
Finfare Inc. Irvine, United StatesJob Description · Job DescriptionAbout Us · Finfare is dedicated to empowering SMBs, by providing the ultimate expense management solution for growing businesses seeking to streamline their financial operations and maximize cash back rewards. Finfare offers easy expense tracking, ...
-
Sr. Manager of Operations
4 days ago
The Ladders Irvine, United StatesAbout Us · Finfare is dedicated to empowering SMBs, by providing the ultimate expense management solution for growing businesses seeking to streamline their financial operations and maximize cash back rewards. Finfare offers easy expense tracking, personalized spend controls, se ...
-
Warehouse Operations Manager
6 days ago
Kinetic Personnel Group, Inc Irvine, United StatesAre you ready to make a significant impact and drive operational excellence in a dynamic organization? Look no further We are seeking a highly motivated Operations Specialist to play a pivotal role in ensuring seamless operations across various departments. · *Pay:* $80,000 - $9 ...
-
Office/Operations Manager
1 week ago
ServiceMaster Restore 9669 - Irvine Irvine, United StatesBenefits: · Health insurance · Opportunity for advancement · Paid time off · Position Overview · This is a high impact position within our business, we are seeking a person that has the technical and business experience and will thrive in the culture of our organization. The Oper ...
-
Operational Excellence Manager
1 week ago
Insight Global Irvine, United StatesInsight Global is seeking a technical engineering professional to support a large life sciences company in 6 month contract with the high possibility of full-time hire by February 2025. This individual will be supporting 2 senior level directors within their base business initiat ...
-
Business Operations Manager Senior-IO/IT
14 hours ago
Capital Group Irvine, United States Full time"I can take an active role in my career advancement." · You've had ongoing conversations with your manager and you're ready for the next step in your career. Collectively, we're working hard to advance diversity, equity and inclusion in our organization because we know that wh ...
-
Operations Manager
2 weeks ago
Michaels La Habra, United States Temps pleinStore - LA-LA HABRA, CAQue ferez-vous? · Offrir une expérience de magasinage centrée sur la clientèle en gérant et en · obtenant une exploitation de l'aire des caisses efficace et en respectant les attentes. · Diriger les processus omnicanaux. Maintenir les normes de rangement ...
Clinical Research Operations Manager - Irvine, United States - Edwards Lifesciences
Description
Innovation starts from the heart.Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what's currently possible, and create solutions for patients many years into the future.
If you're an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career.
We'll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.
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.
As the Clinical Operations Manager in Advanced Technology (AT), you'll be responsible for managing clinical related activities to provide a platform for study success.
Please note - the position is a subject matter expert (SME) role and will not have any people management duties.
_This role is on-site at our Irvine headquarter full time 4 days with 1 WFH day/week._How you will make an impact:
What you will need (Required):
What else we look for (Preferred):
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.
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.