Director, Clinical Research Monitoring

Director, Clinical Research Monitoring (Remote)- Surgical Structural Heart
Have you been searching for a leadership role that brings you to the forefront of innovation? We have an outstanding leadership opportunity with our Surgical Structural Heart team, focused on developing new and maintaining the best standard for patients suffering from heart valve disease.
As the Director, of Clinical Research Monitoring, you will lead a team of clinical payment specialists and clinical research monitoring professionals and be responsible for managing the strategic direction of field monitoring activities for large-scale trials.
Key Responsibilities include, but not limited to:

• Lead on the strategic direction of field monitoring of studies and data collection for clinical trials (e.g., increased volume, upstream clinical projects) with increased volume and complexity (e.g., KOL site) , provide guidance to the Core Team, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
• Lead and develop consistent manager processes for the BU in partnership with leadership
• Make decisions on the output of clinical trial conduct improvements including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence and create proposal to leadership
• Provide technical guidance in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements to as well as training and proctoring new employees on trial and study related activities to ensure alignment across the BU. Act as a mentor to new managers across the company
• Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all project deliverables. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams
• Lead team members to take appropriate actions on complex trial monitoring issues (e.g., CAPA) and review escalated monitoring visit reports
• Act as a key stakeholder to drive and develop consistent monitoring practices, procedures (e.g., SOPs), and initiatives across the BU in partnership with cross functional teams
• Identify risk, develop and lead in the implementation of broad and more complex monitoring strategies which may include negotiations with internal and external parties
• Manage all payment related activities for Clinical and Medical Affairs
• Manage and oversee the work of multiple functionalities, scope and/or locations and may have financial budget responsibilities. Serve as a subject matter expert to provide monitoring guidance to leadership. Develop a robust talent development plan in alignment with functional growth strategies of the department.

Minimum Education and Experience:

• Minimum of 2-3 years of direct people management experience, including a remote workforce, required
• Ability to travel up to 60% for monitoring/meetings/conferences Covid vaccination, required
• Bachelor's Degree in related field, required
• 12 years of medical device/sponsor/CRO industry work experience in field clinical research monitoring, quality assurance/control & regulatory compliance, required

Preferred Qualifications- in addition to meeting minimum requirements, it would be nice to have the following:

• Experience with large scale pivotal trials, study start-up to closure
• Experience with Medidata CTMS, Medidata RAVE, Coupa, and Veeva Vault
• Prior clinical research experience with Class III Medical Devices including PMA, IDE, 510k
• Knowledge of Cardiovascular Physiology and structural heart anatomy
• Experience with structural heart therapeutic area, is a plus
• Experience with Risk-Based Monitoring

Additional Skills:

• Support and solicit input from team members at all levels
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• Proficient in Microsoft Office Suite, including Word, Excel, and Adobe, and related tools and systems
• 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 interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Expert understanding of multiple areas of expertise in cardiovascular anatomy, pathology and physiology or Business Unit
• Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
• Ability to translate technical information across the organization
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives and effective communication with KOLs
• Expert knowledge of financial mechanism that relates to clinical studies
• Frequently interacts with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
• Excellent presentation and facilitation skills to large groups including senior management
• Develop relationships and leverage them to influence change
• Dedicated to quality client service and pro-active and responsive to client needs.
• Expert understanding of clinical studies procedures while identifying applications of functional knowledge and existing methodologies to complex problems
• Lead briefings and technical meetings for internal and external representatives
• Demonstrated ability to manage one or more teams 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
• Experience with electronic data capture preferred
• Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship

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 $187,000 (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 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.