Clinical Research Associate
3 weeks ago
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
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
Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)
Remote position located in Halifax
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
In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
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.
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