Clinical Trial Manager, Toronto/Markham, Ontario, Canada Location
Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength...that’s us…that’s Everest.
To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Clinical Trial Manager for our Toronto/Markham, Ontario, Canada location.
- Interact with personnel from study sponsors, investigational sites, vendors, and Everest functional groups to enable timely and high quality initiation and completion of clinical trials. This includes broader clinical trial and project management support across Clinical Operations, Biometrics, Safety, and Regulatory functional groups.
- Lead the site feasibility and selection process. Compile documentation for qualification of clinical sites. Support review of the documentation to ensure clinical sites comply with ICH-GCP and relevant local regulations.
- Assist with preparation and submission of regulatory documents to responsible authorities and IRB/ECs.
- Responsible for set-up and maintenance of studies in Clinical Trial Management System (CTMS) and Trial Master File (TMF), working with the Clinical Trial Assistant(s).
- Establish, maintain, and archive files of essential documents from investigative sites and for inclusion in Trial Master Files. These files must be maintained in a fashion so that they are continuously available for audit and completion for archive.
- Assist in review of documentation of information provided to study subjects, including informed consent forms.
- Assist in working with meeting planners and vendors to arrange for investigator meetings, off-site client or internal departmental meetings.
- Liaise across various clinical trial stakeholders to compile reports to track progress/status and clinical trial risks across all investigational sites.
- Contribute to the development of documents that facilitate or describe the management of the clinical trial. Examples of such documents include, study guides or manuals, and information collection tools.
- Responsible for the shipment and tracking of trial documents (site binders, manuals, guides, etc.)
- Record and inventory visit reports received from monitoring staff.
- Work with Everest and vendor staff to maintain study portals, web sites, or newsletters.
- Assist with processing vendor invoices, investigator payments, and expense reports.
- Prompt study team staff to provide timely and accurate reports of travel expenses.
- Participate in the development and maintenance of, and adhere to departmental SOPs and guidelines.
- Support business development efforts directly by supporting task-based activities during RFPs and bid cycles, and indirectly by building trust-based relationships with clients through performance, reliability, and strong customer service.
- Prepare, maintain, and complete training on study-specific and (or) applicable sponsor SOPs.
- Support sites in their efforts to prepare for audits conducted either by sponsors or regulatory authorities.
- Plan and carry out professional development.
- Provide support in Clinical Operations, Project Management, or other functional areas as required.
Qualifications and Experience:
- Bachelor, advanced, or professional degree in life sciences or health related field.
- Minimum of 3 years’ clinical research experience within a pharmaceutical, biotechnology, CRO, or research institute setting. Experience in Project Management is required.
- Strong technical writing ability. Excellent command of verbal and written English.
- Thorough comprehension of medical terminology.
- Demonstrated understanding of clinical site operations, clinical site monitoring, and overall clinical trial processes and procedures.
- Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
- Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.
- Excellent interpersonal skills.
- Demonstrated strong negotiation and presentation skills.
- Strong ability in problem-solving including conflict resolution.
- Coursework in finance or accounting will be desirable.
- Ability to travel as needed, maximum of 50% of working hours may be required.
How to Apply:
Please send your application along with cover letter to [email protected].
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity.
We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.