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Clinical Research Manager

3 months ago

Vancouver, British Columbia, Canada MedSpa Partners Full time

MedSpa Partners (MSP) is North America's largest platform of top-tier medical aesthetics clinics (including plastic surgery, cosmetic dermatology, and med spas) and is one of
Deloitte's Top 25 Best Managed Companies in Canada. Our goal is to allow our industry-leading teams to achieve their professional aspirations by creating world-class patient experiences through sustainable support, collaboration, and community.

MSP Research is a group of Canadas leading Cosmetic Medicine Clinical Research Sites across North America. The
Cosmetic Research Consortium consists of eight clinical research sites and growing. We are looking for a strong clinical research manager who excels in clinical research, organization, and execution; develops schedules, tasks and assignments that align with the planned strategies and produce optimal results.

Responsibilities:

  • Supervises sites daily operations general daily site support
  • Provide supervision, training and leadership to CRC's, LPNs, and RNs in the research team and model continuous improvement
  • Collaborates on staff performance and work distribution changes when applicable especially with allocation of new tasks or responsibilities
  • Ensures that clinical monitoring activities of their assigned team are performed to the Sponsor's satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and studyspecific requirements.
  • Oversees the performance of their direct reports. Implements professional development and performance evaluations.
  • Supports the training and development of Clinical Operations personnel within their remit and ensures team members' consistent use of study tools and training materials.
  • Strong Standard Operating Procedures (SOPs) execution and analysis
  • Tracks Clinical Operations metrics such number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, followup letters, timesheets, expense reports and required trainings.
  • CTMS management and execution
  • Keeps Director apprised and informed of all situations and daily operations
  • Collaborates with Director to develop site protocols and consortium SOPs
  • Escalates problems swiftly to appropriate parties; PI, Sub-I, Site Leads, Director and CRO when applicable
  • Forecasting and identifying risks such as, times of increased workload, vacation, bottlenecks in processes and alerting appropriate PI and Director to help mitigate
  • Meeting weekly with director of Research and Monthly with MSP Leadership
  • Communicate with sponsors and their representatives as well as monitoring agencies or third parties in a respectful manner to schedule and complete tasks
  • Assist in planning and organizing of clinical trial startups including feasibility review, submissions when required
  • Strong background in clinical research regulatory requirements, contract and budget building and negotiations
  • Collaborates and implements methodologies, policies, procedures, and standards in clinical research protocol management to ensure quality data including CAPA & ALCOA
  • Advises key members on internal Quality Control (QC) findings and ways to continually improve
  • Regularly meets deadlines related to individual as well as team performance on projects/assignments.
  • Support audit preparation for any site inspections
  • Abide by and advise sites on Good Clinical Practice (GCP), standard Operating Procedures (SOPs), company guidelines, and local healthcare and privacy regulations
  • Manage quarterly recruitment targets and support efforts to achieve site/company KPIs
  • Interact with key investigators, KOLs and thirdparty vendors to develop durable relationships that will help the region evaluate new opportunities, provide solid feasibility assessment, and ensure collaboration of key sites in the recruitment and preparation of our trial and platform growth
  • Provide insight to MSP Research's management about the best business practices in the target indication

Qualifications:

  • A Bachelor of Science, or Master of Science and/or a level of education, training, and experience equivalent to a Bachelor's or Master's degree in a science discipline or related field such as Health Administration, Nursing, Microbiology, or Business Administration.
  • Five years of recent, related experience in an administrative position related to operations of clinical research management and leadership positions involving the development, implementation and evaluation of complex protocols, Clinical Trials Management Systems (CTMS), and a strong background in regulatory and health guidelines.
  • Dermatology, or aesthetics background an asset but not required

This role will be perfect for you if:

  • You are a Clinical Research Manager with at least five years of managerial or leadership experience
  • You are a clinical resear