Clinical Lead

Job Title: Clinical Lead Job

Location:
Toronto, Ontario, Canada Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients' lives by bringing new drugs to the market faster. The Clinical Lead is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Clinical Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times. Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans). Accountable for meeting projects' recruitment targets and ensuring appropriate recruitment strategies are in place. Contribute to the development of the project risk mitigation plan and manage clinical risks through the project's lifecycle. Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues. Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management. Report to internal and external stakeholders as per project scope requirements. Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings. Support professional development by providing feedback to clinical team line managers on performance relative to project tasks. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership. May work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials. May attend site visits as applicable in support of project delivery. Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required Req Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience. Req Requires basic knowledge of Project management practices and terminology. Req Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.; Req Requires good understanding of Clinical Research industry (drug/device/technology/etc.) Req Requires understanding of project finances. Req Knowledge of clinical trials
- Knowledge of clinical trial conduct in addition to skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct. Communication
- Strong written and verbal communication skills including good command of English language. Organization
- Planning, time management and prioritization skills. Quality
- Attention to detail and accuracy in work. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues. IT skills
- Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.