Precision for Medicine - Senior Manager, Clinical Trial Management
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Requirements
• Graduate, postgraduate, 4-year college degree or equivalent experience ideally in a scientific or health related field • 10 years of industry experience in clinical research, including clinical operations experience in a pharmaceutical company or CRO, or proven competencies for this position • Experience in managing clinical aspects of complex and global trials • Previous CTM line management experience • Working knowledge of ICH GCP guidelines and the clinical development process • Excellent communication and interpersonal skills to effectively interface with others in a team setting • Excellent organizational skills, attention to detail, and a customer service demeanor • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) • Ability to travel domestically and internationally including overnight stays • Competencies: • Direct work experience in a global, cross-functional clinical management environment • Proven experience in people management with a high capacity for Emotional Intelligence • Ability to develop, coach and mentor CTM staff and hold personnel accountable to achieve goals and address training needs • Proven experience in risk management and change management • High level of integrity and must inspire and demand the highest standards from assigned CTMs • Exhibits high self-motivation, and the ability to work and plan independently as well as in a team environment • Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills • Excellent presentation, verbal, and written communications skills • Demonstrated successful independent negotiation and conflict management strategies • Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and team • Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Responsibilities
• This position requires the ability to independently lead, manage, and motivate a team of CTMs and Managers (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. The Manager will ensure studies are conducted in accordance with applicable SOPs, regulations, and ICH GCP principles. • Essential functions of the job include but are not limited to: • Lead, mentor, coach, and manage CTMs/PCTMs/MCTMs to support skill development, performance, and career growth in line with Precision for Medicine quality standards. • Provide leadership and oversight across clinical programs, including clinical trial oversight where applicable. • Partner with Clinical Operations leadership and cross-functional teams to improve CTM processes, quality, consistency, efficiency, and KPI achievement. • Collaborate with Resourcing to ensure appropriate staffing and resource allocation. • Set strategic action plans and provide ongoing performance feedback, technical guidance, and developmental support to direct reports.Ensure CTMs have appropriate training, tools, systems access, and resources to meet role expectations. • Identify quality risks, recommend corrective actions, and escalate issues as needed to leadership, PMs, and DPMs.Ensure compliance with SOPs, regulatory requirements, project plans, and quality standards. • Develop and update Clinical Operations SOPs, templates, and work instructions; contribute to clinical documentation as needed. • Support CTM hiring, onboarding, and training in collaboration with HR and Learning & Development. • Promote Precision’s values and complete additional duties as assigned by leadership.
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