Senior Clinical Trial Lead

Troy - Michigan - United States - Life Sciences & Health Care - Medical devices - Clinical - Academic Bachelor

Our client is known as the leader in the science behind the diagnosis and treatment of cardiac arrhythmias or irregular heartbeat, through the use of cardiovascular-specific medical devices.

Feel free to contact

Maria Camanag, Account manager

Apply now

About this role

  • Clinical study execution in support of the Client’s team and their overall Clinical Center of Excellence with a focus primarily on clinical cardiovascular studies.
  • Fostering strong, productive relationships with colleagues within the organization
  • Serving as a member or leader of the study core team and may serve as the liaison with the operating company for projects under his/her responsibility
  • Overall execution of small-medium-large regulated and non-regulated clinical projects or large non-regulated clinical projects including, but not limited to budget tracking, tracking and supporting subject recruitment, monitoring, quality of deliverables, site support and study closure
  • Providing support to department wide training
  • Quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical projects
  • Leading several small/medium/large clinical studies (regulated and non-regulated) that may involve Clinical Research Associates (CRAs) and/or other clinical operations staff.
  • Assisting with or leading the management of large regulated studies alongside and in support of colleague CPMs or Senior CPMs and may support CPMs and/or Senior CPMs within a large or complex clinical study.
  • Identifying and ensuring strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical studies under his/her responsibilities.
  • Managing all activities of assigned clinical studies within the Clinical R&D Operations group.
  • Functioning as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
  • Evaluating support requests for publications and to provide consolidated comments and support to the requests.
  • Managing Resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
  • Tracking assigned projects budgets to ensure adherence to business plans.
  • Supporting the implementation of new clinical systems/processes, and provide support for publications, as needed
  • Independently solves problems arising during clinical study execution and will seek guidance for more complex problems as needed
  • Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
  • Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
  • Providing quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies
  • May serve as the primary contact for clinical trial sites

About you

  • A minimum of a Bachelor’s Degree required: Life Science, Physical Science, Nursing, or Biological Science degree is preferred
  • 5+ years of experience required as CRO- or Sponsor-level CRA or Clinical Project Manager
  • 1+ years of Clinical Project Management experience
  • Cardiovascular clinical trial experience strongly preferred
  • Personnel management experience strongly preferred
  • Medical device experience is preferred
  • The ability to influence others along with strong written and oral communication skills is required
  • Knowledge of Good Clinical Practices is required
  • Understanding and application of regulations and standards applied in clinical areas is required
  • Advanced project management skills with the ability to handle multiple projects required
  • Relevant industry certifications preferred (i.e., CCRA, RAC, CDE)
  • Strong written and oral communication skills

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB213406
  • Location: Troy
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Medical devices
  • Education level: Academic Bachelor
  • Area of Expertise: Clinical
  • Closing date: Saturday, July 6, 2019
Apply now

Feel free to contact

MC

Maria Camanag

Account manager Brunel Canada Toronto

+1 416 244 2402

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