Senior Manager, Clinical Programming

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.As the Senior Manager, Clinical Programming , you will provide direction to a team and responsible for ensuring data-related activities for multiple clinical trials.This position can be onsite, hybrid or remote. For remote candidates, ideal locations are in or near the following cities:-Irvine, CA-San Diego, CA-San Francisco, CA-Seattle, WA-Portland, OR-Denver, CO-Phoenix, AZ-Houston, TX-Dallas, TX-Minneapolis, MN-Chicago, IL-Nashville, TN-Cincinnati, OH-Philadelphia, PA-Newark, NJ-Boston, MA-Baltimore, MD-Raleigh, NC-Atlanta, GA-Jacksonville, FLKey Responsibilities include but not limited to :

Participate in all aspects of clinical system programming for all concurrent projects from clinical study start-up to conduct and study closeout. Act as a consultant in data management processes and principles for all projects and other functional groups

Manage a team of clinical programmers and analysts at multiple professional levels to ensure a successful achievement of the departmental goals and project milestones

Provide clinical programming solutions/guidance and risk mitigation advice to direct reports and/or project teams for operational issues through the use of available data, tools, feedback and discussions

Manage resource assignments for all concurrent and future clinical study projects and activities with accountability for successful completion of all operational milestones for direct reports

Monitor general progress to ensure clinical programming milestones and deliverables are met with quality for all concurrent projects

Liaise with functional vendors in a project-manager capacity in support of timelines and data activities

Lead process improvement projects within CDM and across functional areas

Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to clinical programming to ensure compliance, accuracy, efficiency, and optimization

Make resource planning and budgetary recommendations on operational expenditure planning and other financial activities

Required Qualifications:

Bachelor's Degree

Ability to travel up to 25%

Medidata Rave with custom function experience

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

Expert understanding of clinical programming procedures while addressing issues with impact beyond own team based on knowledge of related disciplines

Expert understanding of related aspects of clinical programming processes and/or systems

Support system integrations with Medidata and/or outside of Medidata

Preferred Qualifications:

Master's Degree

Medical device experience

2 years of people leadership experience

Proven successful project management leadership skills

Experience with CDISC, CDASH and some exposure to SDTM datasets

Familiarity with data lake concepts

Experience with RTMS (Randomization and/or Supply Management)

Use of various programming languages to support manual report generation to support data cleaning activities

General Skills:

Proven expertise in Microsoft Office Suite and related tools and systems

Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting

Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations

Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical programming to the business

Frequently interacts 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 team

Dedicated to quality client service and proactive and responsive to client needs

Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness

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

Ability to work in an agile environment to support our clinical study needs

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 $141,000 to $200,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.