Senior Manager, Clinical Research Monitoring (Remote)
Senior Manager, Clinical Research Monitoring (Remote), Surgical Structural HeartHave 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 Senior Manager, 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:
Manage and oversee the work of assigned team within own function and may indirectly manage cross functional or matrix teams as appropriate.
Responsible for team budget and outside contractors/vendors.
Develop a robust talent development plan in alignment with functional growth strategies of the department 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), act as a Core Team lead, 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 Provide guidance to team for clinical trial conduct improvements including management of metrics (e.
g.
, dashboard), compliance, protocol deviations, and data entry cadence Lead in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities Act as a mentor to new or other employees across the company Lead team members to take appropriate actions on complex trial monitoring issues (e.
g.
, CAPA) and review escalated monitoring visit reports Participate and contribute to the development of clinical protocols, and informed consent forms, and case report forms Resolve complex trial/study data and regulatory documentation Provide direction and guidance to execute project deliverables in collaboration with project managers Initiate and lead the implementation on clinical process improvement opportunities Other incidental duties Minimum Education and Experience Bachelor's Degree in related field, required 10 years of medical device/sponsor/CRO industry work experience in field clinical research monitoring, quality assurance/control & regulatory compliance, required OR 8 years of medical device/sponsor/CRO industry work experience in field clinical research monitoring, quality assurance/control & regulatory compliance experience and a Masters Degree in related field Minimum of 1-2 years of direct people management experience, including a remote workforce, required Ability to travel up to 50% for monitoring visits/meetings/conferences Covid vaccination, required Preferred Qualifications- in addition to meeting minimum requirements, it would be nice to have the following:
Experience with Risk-Based Monitoring Experience with structural heart therapeutic area, is a plus Experience with large scale pivotal trials, study start-up to closure Knowledge of Cardiovascular Physiology and structural heart anatomy Prior clinical research experience with Class III Medical Devices including PMA, IDE, 510k Experience with Medidata CTMS, Medidata RAVE, Coupa, and Veeva Vault Additional Skills Proven expertise in MS Office Suite, including Word, Excel, and Adobe Experience with electronic data capture preferred Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives Excellent problem-solving, organizational, analytical and critical thinking skills Expert understanding of clinical studies procedures while addressing issues with impact beyond own team based on knowledge of related disciplines Expert understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise 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 Strict attention to detail Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization Ability to work and excel within a fast paced, dynamic, and constantly changing work environment Frequently interacts with customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team Participate and present at meetings with internal and external representatives Resolve operational and scheduling issues Dedicated to quality client service and pro-active and responsive to client needs.
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Develop relationships and leverage them to influence change Support and solicit input from team members at all levels within the organization 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 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 base pay range for this position is $123,000 to $174,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.
g.
, geographic location, 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.
Recommended Skills Biopharmaceuticals Clinical Research Clinical Trials Good Clinical Practice Biotechnology Biostatistics Estimated Salary: $20 to $28 per hour based on qualifications.
As the Senior Manager, 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:
Manage and oversee the work of assigned team within own function and may indirectly manage cross functional or matrix teams as appropriate.
Responsible for team budget and outside contractors/vendors.
Develop a robust talent development plan in alignment with functional growth strategies of the department 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), act as a Core Team lead, 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 Provide guidance to team for clinical trial conduct improvements including management of metrics (e.
g.
, dashboard), compliance, protocol deviations, and data entry cadence Lead in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities Act as a mentor to new or other employees across the company Lead team members to take appropriate actions on complex trial monitoring issues (e.
g.
, CAPA) and review escalated monitoring visit reports Participate and contribute to the development of clinical protocols, and informed consent forms, and case report forms Resolve complex trial/study data and regulatory documentation Provide direction and guidance to execute project deliverables in collaboration with project managers Initiate and lead the implementation on clinical process improvement opportunities Other incidental duties Minimum Education and Experience Bachelor's Degree in related field, required 10 years of medical device/sponsor/CRO industry work experience in field clinical research monitoring, quality assurance/control & regulatory compliance, required OR 8 years of medical device/sponsor/CRO industry work experience in field clinical research monitoring, quality assurance/control & regulatory compliance experience and a Masters Degree in related field Minimum of 1-2 years of direct people management experience, including a remote workforce, required Ability to travel up to 50% for monitoring visits/meetings/conferences Covid vaccination, required Preferred Qualifications- in addition to meeting minimum requirements, it would be nice to have the following:
Experience with Risk-Based Monitoring Experience with structural heart therapeutic area, is a plus Experience with large scale pivotal trials, study start-up to closure Knowledge of Cardiovascular Physiology and structural heart anatomy Prior clinical research experience with Class III Medical Devices including PMA, IDE, 510k Experience with Medidata CTMS, Medidata RAVE, Coupa, and Veeva Vault Additional Skills Proven expertise in MS Office Suite, including Word, Excel, and Adobe Experience with electronic data capture preferred Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives Excellent problem-solving, organizational, analytical and critical thinking skills Expert understanding of clinical studies procedures while addressing issues with impact beyond own team based on knowledge of related disciplines Expert understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise 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 Strict attention to detail Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization Ability to work and excel within a fast paced, dynamic, and constantly changing work environment Frequently interacts with customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team Participate and present at meetings with internal and external representatives Resolve operational and scheduling issues Dedicated to quality client service and pro-active and responsive to client needs.
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Develop relationships and leverage them to influence change Support and solicit input from team members at all levels within the organization 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 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 base pay range for this position is $123,000 to $174,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.
g.
, geographic location, 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.
Recommended Skills Biopharmaceuticals Clinical Research Clinical Trials Good Clinical Practice Biotechnology Biostatistics Estimated Salary: $20 to $28 per hour based on qualifications.
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