As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
- Oversee multiple oncology trials, ensuring high-quality execution
- Provide leadership and mentorship to junior flex team members
- Act as Lead SM, training and guiding other Site Managers on study protocols
- Develop essential study start-up documents, including SIV agendas
- Represent Site Managers and Lead Trial Managers (LTMs) in key meetings
- Ensure the SM perspective is reflected in study documents like Monitoring Guidelines
- Review reports (SQV, SMV, SCV) for sites assigned to other SMs within the same trial
- Support country budget development and contract negotiations in collaboration with CCS colleagues
- Assist with ASV activities and ensure alignment with study objectives
- Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)
You Are:
- Remote position located in Toronto
- Bilingual - Proficient in both written and spoken French and English.
- Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
- At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
- Experience in multiple therapeutic areas is an asset, particularly in oncology (Hematology, Prostate Cancer, Lung Cancer, Early Development - Phase 1)
- Knowledge of risk-based/analytical monitoring approaches is an asset
- Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
- Ability to actively drive patient recruitment strategies at assigned sites
- Strong collaboration with investigators and site staff to meet study timelines
- Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
- Ability to work independently while being a strong collaborator
- In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
- Up to 50% regional travel required
- To qualify, applicants must be legally authorized to work in Canada and should not require, now or in the future, sponsorship for employment visa status.
