The Research Project Manager II is to lead a team in the central coordination of one or more multi-centre research studies and to act as the primary point of contact for internal departments and external stakeholders. Responsibilities include: Review and provide input into research study protocols; Develop and design materials to assist in conduct of study, including informed consent form templates, recruitment materials, manual of operations, training material; Liaise and coordinate with internal departments to ensure requirements and timelines are achieved as required; Support the Principal Investigator (PI) in the identification, development and organization of required study committees; Monitor study management plans throughout project; Control for risk identification, risk mitigation and issue resolution for the research study; Prepare and present reports, abstracts, posters, and academic manuscripts;. Ongoing management of data collection and validation systems, processes, and associated documentation; Development of research study budgets; Negotiate budgets with vendors, sites and national leaders; Provide leadership, coaching, training and mentorship to study team members; manage the performance and workload for study team members; Develop targets and timelines for deliverables, anticipates potential delays and proactively develop strategies to achieve a positive outcome; Represents the research study team at program and other organizational meetings; and Negotiate and resolve conflicts among study team members.
- Minimum 5 years’ experience in multi-centre research studies and the management of large clinical research datasets.
- Undergraduate degree in sciences or health science and a clinical research certification (CCRP, ACRP or other post-graduate certification in clinical research).
- Minimum 3 years supervisory experience.
- Excellent communication, problem solving skills and ability to work flexible hours.
- Knowledge of ICH-GCP Guidelines and international research requirements.
- Broad knowledge of research methodology, clinical trials and drug development processes.
