Mentors/coaches junior flex team
Acts as Lead SM-training other SMs on study
Develops site start up documents for studies including SIV agenda
Provides SM “voice” when reviewing study documents (e.G. Monitoring Guidelines)
Represents LTMs or SMs on SMTs/meetings
Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
Supports country budget development and/or contract negotiation in liaison with CCS colleagues
Assists with ASV
Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces – Primary/Other:
Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and theirdelegates at site (trial personnel including study coordinators, pharmacists, etc.)
What you need to have:
Based in the Montreal area, Quebec
Bilingual – French and English
Have a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
Have a minimum of 2 year experience in monitoring pharmaceutical industry clinical trials
Knowledge of several therapeutic areas is an asset, including oncology – preferably Hematology, Prostate Cancer, Lung Cancer, Early development (Phase 1) etc.
Analytical/risk-based monitoring experience is an asset
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet all study timelines
Ability to operate and use various systems and databases (e.G. CTMS, EDC, TMF, various dashboards/metrics, IWRS, safety reporting).
Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
Need to travel up to 50%
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.