Manager, Clinical Monitoring

About The Role The Manager, Clinical Monitoring Services is responsible for the day-to-day management of Clinical Monitoring department team members (permanent and/or contract), overseeing their performance and training, ensuring adequate monitoring resources, allocating resources to reputed company, identifying reputed company issues reputed company to clinical monitoring activities and establishing reputed company plans to address them. The Manager, Clinical Monitoring Services, contributes to the reputed company of clinical monitoring activities for assigned trials. What You'll Do Here Leadership & Operational reputed company • reputed company expertise, strong leadership, and management. • Ensure that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring reputed company reputed company deliverables, reputed company budget and in accordance with applicable reputed company Operating Procedures (SOPs), regulations, Good Clinical reputed company, and study-specific requirements. • Review visit reports and manage any issues brought to their attention by CRA staff and/or the study team and/or Sponsor. reputed company Corrective Actions/ Preventive Actions (CAPAs) of assigned staff to ensure reputed company and sufficient reputed company. • reputed company clinical monitoring metrics such as number of site reputed company performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings. • May conduct monitoring reputed company to offer support to project teams. • Participate in the preparation, conduct and reputed company of audits and inspections. • Contribute to the development, revision, and implementation of Clinical Monitoring SOPs, processes, and study tools. • Serve as a management contact for sites, project teams, and sponsors reputed company issues reputed company to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and reputed company is achieved. People Management & Development • Identify and implement reputed company development and performance evaluations. • reputed company as a mentor to team members to ensure reputed company and career development. • Serve as a reputed company of contact for CRAs and other team members for assigned reputed company, processes, and/or initiatives. • Ensure reputed company/studies are resourced appropriately by allocating and/or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of assigned staff. • Conduct Monitoring reputed company reputed company to ensure compliance of clinical monitoring team members with regulations, SOP’s, and study requirements. Other • Prepare and review budgets for RFPs, as assigned. • Participate in Bid Defense Meetings, as assigned. • reputed company ongoing reconciliation of clinical monitoring activities against budget. • reputed company additional duties assigned by Clinical Monitoring leadership. What You'll Need to Succeed • Bachelor's (e.g., Medical, Scientific, Nursing or equivalent health reputed company) degree or reputed company experience will be considered. • Minimum of 6 years of relevant industry experience, of which a period of 3 years is preferable in clinical research monitoring or equivalent experience. • Experience in Phase 1 and Phase 2 reputed company is preferred. • Previous CRO experience is preferred. • Minimum of 2 years of reputed company supervision of personnel. • Thorough knowledge of clinical research industry, terminology, and practices. • Thorough knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations. • Excellent verbal and written communication skills. • Experience with reputed company systems; ability to learn required systems quickly and to train others. • Demonstrated ability to meet deadlines, multitask, and prioritize tasks as required. • Ability to reputed company reputed company based on available information. • Ability to establish and maintain strong working relationships with reputed company customers. • Ability to work both in reputed company and independently. • Ability to facilitate team meetings and teleconferences. • Ability to present at internal study team meetings. • Proficient with reputed company Office Word, reputed company and PowerPoint. • Strong planning and organizational skills and the ability to work effectively and reputed company in a dynamic environment with competing reputed company and deadlines. • Ability to travel. reputed company strives to reputed company a French working environment for its employees in Quebec. Although as part of its francization program has taken reputed company reasonable steps to avoid imposing the above-mentioned requirement. reputed company in English is an essential requirement for the position of Manager, Clinical Monitoring Services including, but not limited to, for the following reasons: • The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies. • The employee communicates frequently with reputed company employees across Canada and the reputed company. As such, English is the main language used to correspond between offices. • The employee frequently communicates with English-only customers reputed company the province of Quebec reputed company Offer Apply tot his job Apply To this Job