Clinical Research Manager

Toronto - Ontario - Canada - Life Sciences & Health Care - Medical devices - Research & Development - Other

Reporting to the Senior Director, Product Marketing & Clinical Affairs, the Clinical Research Manager will be responsible for leading all phases of clinical research for new and existing devices. Clinical responsibilities for leading range from concept/feasibility stages through Regulatory clearances and post market evaluations.

Feel free to contact

Diana Grodowski, Account manager

Apply now

About this role

RESPONSIBILITIES:

  • Prepare clinical development plans for new devices or modifications to existing devices;
  • Identify timelines, resource requirements and budgets for multiple clinical studies;
  • Outline proper study design & documentation including but not limited to Protocol, CRF, ICF, SIV as well as Source and Regulatory documentation as required;
  • Manage process from Study execution through completion, data analysis, summary and creation of scientific papers or abstracts;
  • Ability to Identify/Recommend investigators as well as initiate clinical studies and provide staff training;
  • Monitor clinical investigations, assuring protocol compliance, subject welfare and data integrity;
  • Ensure compliance with Corporate SOPs and Regulatory Authorities;
  • Maintain Clinical File structure according to standard GCP policies and regulatory guidance;
  • Maintain strong professional relationships with Key Opinion Leaders and Clinical Research sites.

About you

QUALIFICATIONS:

  • BS, RN or Master’s degree in medical life sciences;
  • Five or more years as Clinical Research Associate or equivalent;
  • Minimum 2-3 years in Clinical Research Supervisory role;
  • Strong interpersonal skills in the management and development of employees;
  • Excellent analytical, organizational, and problem-solving skills;
  • Ability to function as an independent investigator and able to multitask and prioritize tasks;
  • Experience with energy-based devices;
  • GCP or Clinical Trial Design certification (medical device a plus);
  • Complete understanding of Regulatory / GCP guidelines associated with research programs;
  • Must have a valid driver’s license and a valid passport;
  • Excellent writing, presentation and communication skills;
  • Fluent in English, both written and verbal;
  • Flexibility for occasional evening or weekend work, worldwide travel as needed -25-50 % (worldwide travel).

What we offer

Brunel Life Sciences provides global staffing, recruitment, and contracting solutions for Life Sciences, Pharmaceutical, Biotechnology and Healthcare organizations

About us

Our client is seeking a dedicated Clinical Device Research
Manager to join their reputable medical device company. They are
offering a competitive compensation package, a collaborative work environment
and an excellent work/life balance. Apply now if you are interested in this
exciting and challenging full-time position.

Summary

  • Vacancy number: PUB184593
  • Location: Toronto
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Medical devices
  • Education level: Other
  • Area of Expertise: Research & Development
  • Closing date: Sunday, December 16, 2018
Apply now

Feel free to contact

DG

Diana Grodowski

Account manager Brunel Canada Toronto

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