Clinical Trial Manager - Canada
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- As an employee of our company you will have the potential to make a difference to both patients and society.
- In 1923 our Danish founders began a journey to change diabetes.
- Today, we are thousands of employees across the world with the passion, the skills and the commitment to continue this journey to prevent, treat and ultimately cure diabetes and aspire to change possibilities in hemophilia and other chronic diseases.
- By improving treatment we will not only keep patients healthy and productive, but we also help their families and their communities.
- We employ more than 42,600 employees in 75 countries who strive to make a difference every day.
- Join us, and you will have the opportunity to grow and develop your career with a company with high employee commitment and satisfaction and that has been ranked among the best places to work in Canada.So take the next step towards a life-changing career.
- This exciting opportunity for a Clinical Trial Manager role will ensure key milestones are delivered to project timeline and budget.
- In this role you will be ensuring all clinical trials are conducted in compliance with ICH-GCP guidelines, Canadian regulatory requirements, company SOPs and Clinical Development Guidelines. Your goal as a member of the Clinical Development team is to provide continuous assessment and improvement of team processes.
KEY AREAS OF RESPONSIBILITY
- Manages clinical trials from start-up to close-out, ensuring study conduct is in compliance with appropriate SOPs, ICH-GCP guidelines and regulatory requirements.
- Collaborates with internal team members and external trial to ensure study deliverables are on-track to achieve agreed-upon protocol timelines.
- Identifies and selects Principal Investigators by reviewing and assessing completed feasibility to deliver Canadian randomization targets by agreed upon timeline.
- Prepares clinical trial documents by creating, revising, and translating documents and adhering to local guidelines ensuring approval from Health Canada and ethics committees.
- Develops clinical trial budgets, negotiates contract payment terms and analyzes remaining budget on a quarterly basis ensuring achievement of overall study budget.
- Reviews monitoring reports, adhering to local guideline and providing feedback to Monitors ensuring adequate and accurate documentation of activities and issues identified during monitoring visits to adhere to company SOPs.
- Completes system training in order to adhere to reporting timelines to meet required deliverables.
- Manages the Sponsor and Health Authority Regulatory audit process in Canada by providing support to other team members during audit preparation, addressing questions from Auditor and clarifying audit responses.
- Represents our company Investigator meetings and International Study Group meetings presenting Canadian viewpoints, treatment guidelines, recruitment challenges and regulations.
- Establishes communication with Denmark, US, external trial staff and Regional Monitors by providing prompt responses to questions specific to the protocol, contract and payment terms and policies and procedures. Acts as back-up to Clinical Trial Managers and BioPharm Clinical Trial Manager during absences, as requested.
QUALIFICATIONS & COMPETENCIES
- The right candidate for this role will have a Bachelor of Science Degree with at least two years of experience as a clinical monitor and three years or more in clinical research.
- Some competencies for this role include ability to work both independently and within teams, demonstrated project management skills, attention to detail, organized and able to manage competing priorities and exceptional verbal and written communication skills.
- The candidate must also have knowledge of ICH/GCP guidelines, Microsoft Office and Bilingual in English and French is considered an asset.