About the job
Field Clinical Manager:The role of Field Clinical Manager is to oversee the day-to-day activities of the Clinical Specialist team located in the Western U.S, drive clinical excellence through leadership, coaching and developing the clinical specialist team to its highest potential. Additionally, the Field Clinical Manager will work in close collaboration with Sales managers and other departments (including but not limited to the Laboratory, Client Services, and Clinical Research teams) to ensure effective clinical coverage across the region in support of overarching business needs. At Lucid Diagnostics, we believe early detection will make esophageal cancer a disease of the past. We’re using next generation sequencing to fundamentally change the way esophageal precancer is detected. Our groundbreaking EsoGuard DNA test assesses genes from cells collected from the esophagus in a quick, non-invasive procedure. This gives clinicians the ability to detect disease before it progresses to cancer, all without the need for sedation. We’re focused on making a difference in patient care and we are seeking ambitious team members who do the same. Join our passionate, rapidly growing medtech team and help us end the tragedy of deadly esophageal cancer.ROLE RESPONSIBILITIES
- People Development: The Field Clinical Manager is responsible for recruiting, coaching, and supporting individuals to foster a high-performing team environment. When required, recruitment activities comprise identifying/attracting new Clinical Specialists, interview and candidate selection, and supporting new employee onboarding and training. Managers will proactively coach team members in the field and provide constructive feedback, and identify training needs to support and achieve individual and business goals as well as individual development objectives.
- Building and Maintaining Relationships: Managers will play an important role in building and maintaining strong relationships and understanding of customers, key opinion leaders (KOLs), and other collaborators in the field. Attendance and participation will be expected in company sponsored events and meetings, in addition to developing/maintaining collaborative relationships with other functional areas.
- Client Engagement: Collaborate with the Commercial team to engage customers or prospective customers on the product, educating on the clinical advantages and benefits to patients, and drive customer confidence. Collaborate with the Commercial team to support account maintenance and the fostering of strong, sustained relationships with physician clients, their office staff, and patients. The Field Clinical Manager may also support key customers with educational forums as required by commercial/business needs.
- Functional Knowledge and Clinical Excellence: Maintain an expert understanding of the product portfolio and ensure other members of the Clinical Specialist team (namely direct reports) maintain an expert understanding. The manager will develop and maintain a depth of clinical knowledge through published literature, local clinical expertise, and attendance of conferences and educational meetings. He/she will share clinical and technical knowledge and experiences in a way that motivates and effectively educates others. He/she will actively participate in field activities, maintain high standards of technical success in the implementation of the technology, and ensure those standards are also maintained throughout the team. As needed, individuals in this role will also participate in accrual of data and associated administrative activities to support ongoing evidence development.
- Maintain High Standards of Team Performance: Monitor performance and quality metrics for the team, and provide individual coaching as needed to maintain the standards outlined by key performance indicators. The Field Clinical Manager will actively guide and encourage direct reports in supporting initiatives designed to achieve business goals.
- Resource Allocation: Collaborate internally and with other stakeholders to manage resource allocation in a manner that optimizes efficiency while also meeting business needs; this includes but is not limited to human resource management and fiscal responsibility.
- Problem-Solving and Leadership: Serve as a solution-oriented leader by proactively identifying challenges and presenting innovative, actionable solutions. Demonstrate advanced autonomy and decision-making capabilities. Create a team environment which promotes honest and open communication and information sharing. Listens actively and encourages expression of ideas.
- Culture Champion: Promote and embody the company’s One Team, One Mission culture of collaboration, inclusion, and innovation. Model and promote collaboration and work effectively with others to achieve business goals. This includes involving others where appropriate, in decision making.
- Other Duties as Assigned: Adapt to evolving organizational needs and take on additional responsibilities to support the clinical and operational goals of the team.
SKILLS AND QUALIFICATIONS
- Registered Nurse or Nurse Practitioner (preferred but not required).
- Current Basic Life Support (BLS) Certification is preferred.
- Ability to undertake regular domestic travel approximately 50% of the time (required).
- Previous leadership / management experience is highly regarded (5+ years), however less experience may be considered for an exceptional candidate.
- Experience in mentoring and coaching others.
- Strong administrative and organizational skills.
- Effective written and verbal communication skills.
- Exceptional attention to detail and adept in cross-referencing information.
- Ability to self-motivate, prioritize tasks effectively, and work autonomously.
PAVmed Inc. and its subsidiaries are committed to creating a diverse work environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Desired Skills and Experience
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About the job
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.
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.
As the Clinical Research Specialist, you will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.
How you will make an impact:
- Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities
- Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
- Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations
- Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
- Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
- Other incidental duties
What you’ll need (Required):
- Bachelor’s Degree or Equivalent in Life Sciences or Nursing
- 3 years of work experience in clinical research (site management, clinical project management, field monitoring, and/or clinical research coordination) including quality assurance/control and regulatory compliance or field monitoring with experience in the healthcare industry
- Experience in electronic data capture
- Covid vaccination
- Ability to travel up 25%
What else we look for (Preferred):
- Knowledge of cardiovascular physiology and structural heart anatomy
- Previous medical device Clinical Research experience in cardiology
- Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification)
- Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k)
- Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
- Strong written and verbal communication skills, presentation skills, interpersonal relationship skills, and analytical skills are required
- Strong problem-solving and critical thinking skills
- Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
- Moderate understanding of regulatory submissions, reporting, and audits
- Ability to manage confidential information with discretion
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
- Ability to build productive internal/external working relationships
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 Illinois (IL), the base pay range for this position is $85,000 to $115,000 (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 protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.