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Manager Clinical Research Monitor, (West Region)- THV

Company: Edwards Lifesciences
Location: Phoenix
Posted on: September 24, 2022

Job Description:

Manager Clinical Research Monitor, (West Region)-Transcatheter Heart Valve (THV)This is a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease. The Manager of Clinical Research Monitor will ensure trial patients' safety by assuring trials are conducted ethically, within regulatory compliance, data accuracy, and protocol adherence and provide expert knowledge on the strategic direction of monitoring clinical studies. This role will require availability for region based travel up to 75% of time for Western territories travel such as CA, AZ, NV.Key Responsibilities: Provide input on strategic direction on field monitoring of studies and data collection for clinical trials 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 Participate and contribute to the development of Provide input on clinical protocols, and informed consent forms, and case report forms 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 activitiesAct as a mentor to new or junior level employees Provide direction and guidance to execute project deliverables in collaboration with project managers Identify and evaluate clinical process improvement opportunities Oversee clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence Participate in development and validation of case report forms Review monitoring visit reports Resolve complex trial/study data and regulatory documentation discrepancies escalated by junior level employees Review and complete checklist on informed consent forms (ICF) Other incidental dutiesEducation and Experience:

  • Bachelor's Degree, required
  • 8 years work experience of previous field clinical research monitoring experience, quality assurance/control and regulatory compliance, required
  • Experience working in a medical device or regulated industry PreferredAdditional Skills: Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery 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 Extensive knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies Extensive understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise Strong leadership skills and ability to influence change 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 serving as consultant to management Ability to interact with suppliers, vendors and/or customers 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/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.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 or have a valid religious or medical exemption from being vaccinated.

Keywords: Edwards Lifesciences, Phoenix , Manager Clinical Research Monitor, (West Region)- THV, Healthcare , Phoenix, Arizona

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