Senior Manager, Clinical Trial Management

Position Summary:

• The Senior Manager Clinical Trial Management (Sr. MCTM) offers an additional development path for clinical research professionals. Responsibilities focus on the management and career development of the organization’s Clinical Trial Managers (CTM, Sr. CTM, Principal Clinical Trial Managers (PCTM) and MCTMs, as well as supporting the development of departmental initiatives to strengthen the quality and productivity of Clinical Trial Management operations.
• 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:

• Develop, mentor, coach and manage CTMs, PCTMs and MCTMs (if applicable) to progress their skillset as per Precision for Medicine quality standards. Advocate individual growth and career development
• Work with the Clinical Operations Management Team and management of other functional areas to continually improve and enhance CTM expectations and procedures to promote quality, consistency and efficiency while achieving established Key Performance Indicators (KPIs)
• Provide leadership and oversight on clinical programs. May serve in a managerial capacity in a Clinical Trial Oversight on clinical studies
• Collaborate with the Resourcing team to ensure Clinical Operations resource allocations and needs are appropriately met
• Generate action plans and provide developmental/strategic oversight to optimize CTM services, with a focus on high quality delivery of individual/team/departmental goals
• Provide on-going feedback and development to manage the performance of direct reports.
• Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals, and deliverables) to assigned CTMs
• Ensure all assigned CTMs have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
• Identify quality risks and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
• Interact with Project Manager (PM) and/or Director of Project Management (DPM) in the escalation and resolution of clinical study issues, including out of scope activities and resource allocation changes
• Ensure CTMs uphold high quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
• Develop and revise Clinical Operations SOPs, work instructions, forms, and templates
• May develop and review clinical documents such as but not limited to Clinical Monitoring Plan, Reference Manuals, Informed Consent, Site recruitment plans, CRA tracking materials. etc.
• May participate in the interview process for new CTMs and provide on-boarding training for new CTMs and MCTMs in conjunction with Human Resources, Learning and Development and other functional areas
• Ensure CTMs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
• Recognize, exemplify, and adhere to Precision’s values that center on our commitment to quality, our people, clients, and performance
• Perform other duties and departmental initiatives as assigned by Leadership

Qualifications:

Minimum Required:

• 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
• 5 years direct supervisory/line management experience in clinical research, preferably with CTMs or CRAs
• Working knowledge of ICH GCP guidelines and the clinical development process

Other Required:

• 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
• Ability to travel domestically and internationally including overnight stays

Preferred:

• Experience in managing clinical aspects of complex and global trials
• Experience in management of CTM line managers (Manager level)

Skills:

• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)

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