Employment Opportunities:

Clinical Trial Manager – Markham Location

Reporting to Manager, Clinical Affairs, the CTM will be able to independently organize and manage multiple tasks related to clinical studies of varying type and complexity; while simultaneously ensuring study milestones are met and completed according to the protocol, regulatory requirements and Cytochroma standard operating procedures. The CTM directly interfaces with data management and biostatistics, field clinical monitors, medical directors, and acts as a primary liaison with investigators and clinical site staff.

Responsibilities:

• Participates in the design and planning of clinical research projects.
• Generates clinical study plan including timeline projection and monitoring strategy and schedule.
• Directly oversees vendor (s) and study team on assigned studies to ensure consistency of methods, interpretation and approach of assigned studies
• Oversees clinical trial sites, in accordance with ICH GCP, FDA and TPD guidelines and Cytochroma standard operating procedures, monitoring plan, project timelines and projected budget;
• Oversees monitoring activities, including site selection and qualification, periodic monitoring, data query resolution and study close out activities.
• Conducts quality control visits and monitors, as needed
• Contributes to the development of regulatory submissions and clinical documents including, protocols, CRFs, informed consent forms, investigator brochures and other site training and clinical support documents including operations manuals and guidelines
• Utilize clinical knowledge to improve clinical compliance across department and at external sites with compliance issues
• Assist in Audit follow-up including response to audit and site CAPA process and re-training
• Oversees product and trial supply accountability at investigational sites; assist in resolving issues
• Oversees and conducts study-specific teleconferences and investigator meetings, as needed
• Works under general direction. Exercises judgment within generally defined practices and policies in selecting methods and techniques.

Requirements:

• Strong study management track record showing clear proficiency in clinical project management skills, including budget development and tracking, site monitoring and CRA oversight. 
• Solid vendor management skills
• Broad understanding of operations including those in related development functions
• Demonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug development
• Demonstrated knowledge of ICH GCP, FDA and TPD regulations; certification an asset
• Demonstrates ability to effectively interface with key medical personnel at clinical site(s)
• Demonstrates ability to lead multi-disciplinary teams
• Possesses excellent written and oral communications skills
• Minimum BS/ RN/ Pharmacy Degree or higher and 5+ years of relevant work experience;
• Ability to travel up to 20% of the time.

To apply for this opportunity, please submit your resume in confidence to hr@cytochroma.com. Please ensure that you quote the job title in your email.

We thank all applicants for their interest; however, only candidates under consideration will be contacted. No phone calls please.