Clinical Trial Manager - Cardiovascular (Virtual anywhere in United States)

Location: North Carolina, United States

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This position is no longer open.

Requisition Number: 1712

Position Title: Clinical Trial Manager

External Description:

We are seeking a talented Clinical Trial Manager (CTM) to join us. This is a virtual role that may be based anywhere in the United States. The CTM will work closely with Project Management and a Clinical Research Associate team to lead the delivery of site management clinical operations activities through the coordination of a team of clinical staff globally or within a geographic region. 


The selected candidate is responsible for ensuring site qualification, initiation, interim monitoring, site management, and study close-out activities for studies in accordance with the study protocol and study plan. In addition, the CTM ensures overall quality and timeliness of clinical deliverables for assigned programs and/or region.

Cardio experience is required.

Essential Functions:

  • Actively participate in the implementation and execution of clinical trial activities from study planning through closure; ensure compliance with the clinical monitoring plan
  • Provide leadership and direction to clinical site management team members from study start through closure; training and management of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring, and Sponsor as needed
  • Point of escalation for clinical site management and investigator sites
  • Draft (and finalize) the Clinical Monitoring Plan (CMP) and customization of Worldwide Clinical Trial monitoring visit report/letter templates, site/monitoring tools
  • Assist in the design and development of additional study-related documents including (but not limited to) Informed Consent Form (ICF) templates, Case Report Forms (CRFs), CRF guidelines/instructions Data Management Plan, etc.
  • Track and reports to PM on compliance, trends and study metrics; responsible for the quality of the site data and addressing any identified needs with action plans with measurable metrics to ensure data cleaning is completed as specified
  • Support the PM in ensuring the CRA team is staffed to meet the monitoring demands of the project or program in compliance with the approved budget and CMP; support PM in the development of, and implementation of, recruitment strategy in countries and sites assigned. Leads the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on target.
  • Follow up with CRAs regarding visits schedules, outstanding trip reports and follow up letters; review/finalize trip reports according to SOPs, expectations and as outlined in the annotated report
  • May perform site qualification, initiation, interim monitoring, and/or closeout site visits as needed
  • Represent clinical site management on sponsor and other relevant study team calls and may represent the Company as the primary contact on projects
  • Conduct occasional co-visits for a specific study to ensure the quality of the site, of the CRA work and of the study procedures

Other skills and abilities:

  • Ability to lead and motivate a team across locations and cultures
  • Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
  • Excellent oral and written communication, organizational, problem-solving and interpersonal skills
  • Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
  • Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
  • Proficiency with IxRS, EDC systems

 Requirements:

  • Bachelor Degree or Nursing Degree required and a minimum experience of 8 years as a Clinical Research Associate
  • Must have previous experience as a Lead CRA, Clinical Operations Lead or Clinical Trial Manager
  • Cardiovascular experience required
  • Willingness to travel required up to 30%
  • Valid current passport required

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City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Clinical Trial Manager - Cardiovascular (Virtual anywhere in United States)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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