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Job #03661

About our client Our client, a global pharmaceutical company, is focused on the development and commercialization of treatments in dermatology, coagulation disorders, hypertension, infectious diseases and diseases of bone turnover. The company has a strong management team, a diverse pipeline, and empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Clinical Research Manager Ontario Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee and manage the company's Clinical Operations Group in their roles of managing and co-monitoring clinical trials in Canada and elsewhere 2) Manage assigned projects by carrying out all the functions of an International Clinical Trial Manager (ICTM) or National Clinical Trial Manager (NCTM) as defined in company SOPs 3) Provide day-to-day management of the Clinical Operations Group 4) Develop and manage budget for internal expenses in the International Clinical Operation group in Canada 5) Comply with company SOPs, both national and international 6) Plan and conduct clinical trials according to ICH-GCP 7) Draft protocols for approval for proposed clinical trials 8) Plan and complete assigned projects according to projected timelines and budget 9) Assist in the training of the CRAs 10) Determine which investigators will participate in the trial(s) 11) Provide the investigators and the sites with the information required to ensure that the trials are conducted according to ICH-GCP guidelines and SOPs 12) Consult with investigators regarding the trial and for the reporting of serious and/or unexpected adverse events 13) Ensure company staff assigned to projects conduct them according to GCP and company SOPs including site monitoring, drug accountability, adverse event reporting, data validation, data handling, report production, filing and archiving 14) Develop and maintain solid working relationships with parent company and its affiliates in the roles of ICTM and NCTM 15) Maintain and further develop solid working relationships with CROs to facilitate the management of clinical trials 16) Provide effective leadership and instruction for the Clinical Operations Group and project teams 17) Provide ongoing constructive feedback to International Clinical Operations Group and project team members regarding tasks and performance 18) Motivate and coach the Clinical Operations Group in career and personal development 19) Study background material and keep abreast of trends relating to areas of duty 20) Participate in the sales and marketing strategy teams 21) Perform other duties as assigned Requirements 1) MS (MD or Ph.D. preferred) 2) Minimum 5 – 10 years of clinical project management experience 3) Management experience in clinical operations or R&D groups 4) Experience in working with CROs in clinical trial management 5) Strong knowledge of ICH-GCP 6) Proficient in MS Windows Vista, MS Project and Lotus Notes 7) Ability to work well both in a team environment and independently 8) Ability and willingness to travel