A Black Diamond Networks client based out of California needs a project manager who can provide 4 - 6 months of onsite coverage. Our client needs candidates who have a strong understanding of ICH E6 (R2) guidelines who has experience with risk-based monitoring and risk-management plans who can lead external vendors and cross-functional departments on ensuring that relevant guidelines are met. On the job, the consultant will evaluate what needs to happen to bring them into compliance including developing the tools, driving the implementation, and acting on behalf of our client's quality team. The consultant will also be expected to develop reports and present updates/tracking reports to the client's team. The consultant will interact with external vendors and cross-functional teams including, clinical operations, pharmacovigilance, biostats, etc. and should be accountable to all relevant timelines and initiatives. This position is focused on risk-based monitoring and the development of risk management plans within the clinical realm.